Trial Outcomes & Findings for Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer (NCT NCT02431559)
NCT ID: NCT02431559
Last Updated: 2022-10-10
Results Overview
The primary endpoint in Phase 1 and a secondary endpoint in Phase 2 is the safety/tolerability of study treatment. Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the last dose of study treatment. Treatment-emergent AEs are those that occurred or worsened after administration of the first dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Up to 3.05 years
Results posted on
2022-10-10
Participant Flow
Participant milestones
| Measure |
Phase 1, Dose Level 0a
Subjects received pegylated liposomal doxorubicin (PLD) (40 mg/m\^2 intravenously \[IV\] on Day 1 of every cycle) + durvalumab (3 mg/kg every 2 weeks \[Q2W, equivalent to 450 mg every 4 weeks (Q4W)\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 subcutaneous \[SC\]) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
Subjects received the maximum tolerated dose (MTD) determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
6
|
40
|
|
Overall Study
COMPLETED
|
1
|
1
|
2
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
31
|
Reasons for withdrawal
| Measure |
Phase 1, Dose Level 0a
Subjects received pegylated liposomal doxorubicin (PLD) (40 mg/m\^2 intravenously \[IV\] on Day 1 of every cycle) + durvalumab (3 mg/kg every 2 weeks \[Q2W, equivalent to 450 mg every 4 weeks (Q4W)\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 subcutaneous \[SC\]) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
Subjects received the maximum tolerated dose (MTD) determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
4
|
|
Overall Study
Progressive disease
|
2
|
1
|
4
|
22
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.0 years
n=39 Participants
|
55.0 years
n=41 Participants
|
62.5 years
n=35 Participants
|
65.0 years
n=31 Participants
|
64.0 years
n=146 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
40 Participants
n=31 Participants
|
53 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
33 Participants
n=31 Participants
|
46 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
35 Participants
n=31 Participants
|
45 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=39 Participants
|
3 participants
n=41 Participants
|
4 participants
n=35 Participants
|
27 participants
n=31 Participants
|
37 participants
n=146 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=39 Participants
|
1 participants
n=41 Participants
|
2 participants
n=35 Participants
|
13 participants
n=31 Participants
|
16 participants
n=146 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
0
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
34 Participants
n=31 Participants
|
44 Participants
n=146 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
1
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
9 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Up to 3.05 yearsPopulation: The population comprises all subjects who received at least one dose of study treatment.
The primary endpoint in Phase 1 and a secondary endpoint in Phase 2 is the safety/tolerability of study treatment. Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the last dose of study treatment. Treatment-emergent AEs are those that occurred or worsened after administration of the first dose of study treatment.
Outcome measures
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
3 Participants
|
4 Participants
|
6 Participants
|
40 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
TEAE related to any study treatment
|
3 Participants
|
4 Participants
|
6 Participants
|
38 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
TEAE related to durvalumab
|
2 Participants
|
4 Participants
|
5 Participants
|
32 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
TEAE related to PLD
|
3 Participants
|
4 Participants
|
5 Participants
|
37 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
TEAE related to motolimod
|
3 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Serious TEAE
|
0 Participants
|
2 Participants
|
1 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months for each subjectPopulation: The population comprises all subjects who received at least one dose of study treatment.
PFS-6 according to RECIST 1.1 is the primary endpoint in Phase 2 and a secondary endpoint in Phase 1, where PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions (Eisenhauer et al 2009).
Outcome measures
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Progression-free Survival Rate at 6 Months (PFS-6) by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Estimated Using the Kaplan-Meier Method
|
33.3 percentage of participants
Interval 0.9 to 77.4
|
50.0 percentage of participants
Interval 5.8 to 84.5
|
33.3 percentage of participants
Interval 4.6 to 67.6
|
42.9 percentage of participants
Interval 27.0 to 57.8
|
SECONDARY outcome
Timeframe: Up to 36.6 monthsPopulation: The population comprises all subjects who received at least one dose of study treatment.
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 14 days before the first dose of study treatment), every 3 cycles during study treatment, and during on-study follow-up approximately 3 months after the last disease assessment. 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; 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 2009).
Outcome measures
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Number of Subjects With Best Overall Tumor Response by RECIST 1.1
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Best Overall Tumor Response by RECIST 1.1
PR
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Best Overall Tumor Response by RECIST 1.1
SD
|
1 Participants
|
1 Participants
|
1 Participants
|
15 Participants
|
|
Number of Subjects With Best Overall Tumor Response by RECIST 1.1
PD
|
1 Participants
|
2 Participants
|
3 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to 36.6 monthsPopulation: The population comprises all subjects who received at least one dose of study treatment.
PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression according to RECIST 1.1 or to the date of death, if disease progression does not occur. Per RECIST 1.1, PD is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions (Eisenhauer et al 2009).
Outcome measures
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Median PFS by RECIST 1.1 as Estimated Using the Kaplan-Meier Method
|
5.6 months
Interval 2.7 to
Upper level of confidence interval could not be estimated due to small number of patients who progressed
|
5.7 months
Interval 1.5 to 16.1
|
4.3 months
Interval 1.2 to 16.8
|
5.5 months
Interval 2.8 to 8.3
|
SECONDARY outcome
Timeframe: Up to 12 months for each subjectPopulation: The population comprises all subjects who received at least one dose of study treatment.
PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression according to RECIST 1.1 or to the date of death, if disease progression does not occur. Per RECIST 1.1, PD is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions (Eisenhauer et al 2009).
Outcome measures
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
PFS-12 by RECIST 1.1 as Estimated Using the Kaplan-Meier Method
|
33.3 percentage of participants
Interval 0.9 to 77.4
|
25.0 percentage of participants
Interval 0.9 to 66.5
|
16.7 percentage of participants
Interval 0.8 to 51.7
|
29.5 percentage of participants
Interval 15.2 to 45.2
|
SECONDARY outcome
Timeframe: Up to 36.6 monthsPopulation: The population comprises all subjects who received at least one dose of study treatment.
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 14 days before the first dose of study treatment), every 3 cycles during study treatment, and during on-study follow-up approximately 3 months after the last disease assessment. 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 2014).
Outcome measures
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irCR
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irPR
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irSD
|
1 Participants
|
1 Participants
|
1 Participants
|
16 Participants
|
|
Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irPD
|
1 Participants
|
2 Participants
|
3 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months for each subjectPopulation: The population comprises all subjects who received at least one dose of study treatment.
PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB (Bohnsack et al 2014).
Outcome measures
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
PFS-6 by irRECIST as Estimated Using the Kaplan-Meier Method
|
33.3 percent of participants
Interval 0.9 to 77.4
|
50.0 percent of participants
Interval 5.8 to 84.5
|
33.3 percent of participants
Interval 4.6 to 67.6
|
42.6 percent of participants
Interval 26.7 to 57.5
|
SECONDARY outcome
Timeframe: Up to 12 months for each subjectPopulation: The population comprises all subjects who received at least one dose of study treatment.
PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB (Bohnsack et al 2014).
Outcome measures
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
PFS-12 by irRECIST as Estimated Using the Kaplan-Meier Method
|
33.3 percent of participants
Interval 0.9 to 77.4
|
25.0 percent of participants
Interval 0.9 to 66.5
|
16.7 percent of participants
Interval 0.8 to 51.7
|
33.4 percent of participants
Interval 18.8 to 48.7
|
SECONDARY outcome
Timeframe: Up to 36.6 monthsPopulation: The population comprises all subjects who received at least one dose of study treatment.
PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB (Bohnsack et al 2014).
Outcome measures
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Median PFS by irRECIST as Estimated Using the Kaplan-Meier Method
|
5.6 months
Interval 2.7 to
Upper limit of confidence interval was not estimable due to small number of patients with events.
|
5.7 months
Interval 1.5 to 16.1
|
4.3 months
Interval 1.2 to 16.8
|
5.5 months
Interval 3.0 to 8.3
|
SECONDARY outcome
Timeframe: Up to 36.6 monthsPopulation: The population comprises all subjects who received at least one dose of study treatment.
After completion of treatment, all subjects are followed for survival every 3 months for up to 3 years following initiation of study treatment or or for subjects continuing treatment, completion of study treatment whichever was longer. OS is measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up are censored on the date when they were last known to be alive.
Outcome measures
| Measure |
Phase 1, Dose Level 0a
n=3 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 Participants
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 Participants
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method
|
27.7 months
Interval 11.8 to
Upper limit of confidence interval was not estimable due to small number of patients with events.
|
NA months
Interval 4.2 to
Median OS for Phase 1, Dose Level 0b and upper limit of confidence interval were not estimable due to small number of patients with events.
|
12.8 months
Interval 4.0 to
Upper limit of confidence interval was not estimable due to small number of patients with events.
|
17.6 months
Interval 11.6 to
Upper limit of confidence interval was not estimable due to small number of patients with events.
|
Adverse Events
Phase 1, Dose Level 0a
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1, Dose Level 0b
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1, Dose Level +1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase 2
Serious events: 23 serious events
Other events: 40 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Phase 1, Dose Level 0a
n=3 participants at risk
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 participants at risk
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 participants at risk
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 participants at risk
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Bacterial translocation
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Bronchial obstruction
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 bullous
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Fracture
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
General physical health deterioration
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Hip fracture
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Hypercalcaemia
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Ileus
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Infusion related reaction
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Lung infection
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Lymphadenectomy
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Muscular weakness
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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)
Malignant neoplasm progression
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Nutritional condition abnormal
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 fibrosis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 obstruction
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Sepsis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Small intestinal obstruction
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Subileus
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Transient ischaemic attack
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 tract obstruction
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Wound dehiscence
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Wound complication
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Radiculitis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Tumour excision
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Aphasia
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Ascites
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 |
Phase 1, Dose Level 0a
n=3 participants at risk
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
|
Phase 1, Dose Level 0b
n=4 participants at risk
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 1, Dose Level +1
n=6 participants at risk
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
|
Phase 2
n=40 participants at risk
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
33.3%
2/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
22.5%
9/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
8/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
12.5%
5/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Amylase increased
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
17.5%
7/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
17.5%
7/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Anal fissure
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Anal haemorrhage
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
8/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 creatinine increased
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 folate decreased
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 lactate dehydrogenase increased
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Bronchitis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Catheter site pain
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Chest discomfort
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
66.7%
2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
100.0%
6/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
4/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Conjunctival ulcer
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
33.3%
2/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
27.5%
11/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
33.3%
2/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
27.5%
11/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
C-reactive protein increased
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
12.5%
5/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Cystitis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
75.0%
3/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
22.5%
9/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Deep vein thrombosis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
33.3%
2/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
10/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Dry eye
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Dry skin
|
66.7%
2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
4/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Dyspepsia
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
33.3%
2/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Dysphonia psychogenic
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
8/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Dysuria
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Embolism
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Eye pain
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
100.0%
3/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
75.0%
3/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
66.7%
4/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
52.5%
21/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Feeling cold
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Folliculitis
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Gamma-glutamyltransferase increased
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Gastrointestinal pain
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
33.3%
2/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
12.5%
5/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Groin pain
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Haematoma
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Haemorrhoids
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
66.7%
2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
4/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Hyperkeratosis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
4/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Hyperthyroidism
|
66.7%
2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
4/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Hypoalbuminaemia
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
15.0%
6/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
17.5%
7/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Hyponatraemia
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
12.5%
5/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Hypophosphataemia
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Hypothyroidism
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
33.3%
2/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Influenza
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
100.0%
3/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Infusion related reaction
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Injection site discolouration
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Injection site erythema
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Injection site pain
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Injection site reaction
|
100.0%
3/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
75.0%
3/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
83.3%
5/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Injection site vesicles
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
17.5%
7/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Laryngeal inflammation
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
15.0%
6/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Lymphocyte count decreased
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
10/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Meniscus injury
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
4/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
12.5%
5/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
100.0%
4/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
3/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
47.5%
19/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Neutrophil count decreased
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Night sweats
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Oral candidiasis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Oral pain
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Otitis media
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Palmar-plantar erythrodysaesthesia syndrome
|
66.7%
2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
3/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
57.5%
23/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Pericardial effusion
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Photosensitivity reaction
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Platelet count decreased
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Pneumonia
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Pollakiuria
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Post procedural haematoma
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Procedural pain
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
12.5%
5/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Productive cough
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
27.5%
11/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Pyelonephritis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
66.7%
2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
83.3%
5/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
10/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
15.0%
6/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
100.0%
3/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
33.3%
2/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
47.5%
19/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Renal colic
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Renal failure acute
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Respiratory tract infection
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Rhinorrhoea
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Sciatica
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Sensation of foreign body
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 bradycardia
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 exfoliation
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 hyperpigmentation
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
3/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 induration
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
66.7%
2/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
2/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
66.7%
4/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
45.0%
18/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 incontinence
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 tract pain
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Vaginal discharge
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
2.5%
1/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Viral skin infection
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Vitamin B12 deficiency
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
75.0%
3/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
3/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
27.5%
11/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Vulvovaginal candidiasis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
15.0%
6/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
33.3%
1/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
White blood cell count decreased
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
7.5%
3/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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 lower
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Catheter site rash
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Nasopharyngitis
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Hyperglycemia
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
16.7%
1/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Vitamin D deficiency
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Muscular weakness
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
Throat irritation
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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
|
0.00%
0/3 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/4 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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%
0/6 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
5.0%
2/40 • All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment [up to 3.05 years]) are documented, regardless of the causal relationship to study drug. AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs).
AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to 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