Trial Outcomes & Findings for A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms (NCT NCT05787496)
NCT ID: NCT05787496
Last Updated: 2026-01-28
Results Overview
Toxicity grading per NCI CTCAE v5.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Up to 23 months
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
2mg/kg NC525
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
9mg/kg NC525
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
11
|
4
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
2
|
5
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
6
|
1
|
2
|
Reasons for withdrawal
| Measure |
2mg/kg NC525
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
9mg/kg NC525
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Study Terminated by sponsor
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
2
|
1
|
1
|
4
|
1
|
2
|
Baseline Characteristics
A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms
Baseline characteristics by cohort
| Measure |
2mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
9mg/kg NC525
n=11 Participants
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 8.96 • n=41 Participants
|
65.8 years
STANDARD_DEVIATION 19.87 • n=1581 Participants
|
66.0 years
STANDARD_DEVIATION 10.54 • n=4626 Participants
|
69.6 years
STANDARD_DEVIATION 12.86 • n=72 Participants
|
52.8 years
STANDARD_DEVIATION 17.97
|
56.7 years
STANDARD_DEVIATION 24.01 • n=140 Participants
|
64.0 years
STANDARD_DEVIATION 15.40 • n=58 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
4 Participants
n=72 Participants
|
2 Participants
|
1 Participants
n=140 Participants
|
13 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
7 Participants
n=72 Participants
|
2 Participants
|
2 Participants
n=140 Participants
|
15 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
1 Participants
|
1 Participants
n=140 Participants
|
6 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
9 Participants
n=72 Participants
|
3 Participants
|
2 Participants
n=140 Participants
|
22 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
1 Participants
|
1 Participants
n=140 Participants
|
2 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
2 Participants
n=58 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
9 Participants
n=72 Participants
|
2 Participants
|
2 Participants
n=140 Participants
|
21 Participants
n=58 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
1 Participants
|
0 Participants
n=140 Participants
|
1 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
2 Participants
n=58 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=41 Participants
|
4 participants
n=1581 Participants
|
3 participants
n=4626 Participants
|
11 participants
n=72 Participants
|
4 participants
|
3 participants
n=140 Participants
|
28 participants
n=58 Participants
|
PRIMARY outcome
Timeframe: Up to 23 monthsPopulation: Safety Analysis Set (SAS): The SAS will include all the subjects who receive any amount of NC525 and will be used for summaries and analyses of safety data.
Toxicity grading per NCI CTCAE v5.0.
Outcome measures
| Measure |
9mg/kg NC525
n=11 Participants
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
2mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
To Evaluate the Frequency, Duration, and Severity of Treatment-emergent Adverse Events [Safety and Tolerability].
|
11 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 56 daysPopulation: Safety Analysis Set (SAS): The SAS will include all the subjects who receive any amount of NC525 and will be used for summaries and analyses of safety data
Toxicity grading per NCI CTCAE v5.0.
Outcome measures
| Measure |
9mg/kg NC525
n=11 Participants
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
2mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
To Evaluate Dose-limiting Toxicities (DLTs) of NC525.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Until disease progression, up to 23 monthsPopulation: Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Outcome measures
| Measure |
9mg/kg NC525
n=11 Participants
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
2mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
To Evaluate the Clinical Benefit of NC525 by Assessing Objective Response (OR).
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Until disease progression, up to 23 monthsPopulation: Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Outcome measures
| Measure |
9mg/kg NC525
n=11 Participants
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
2mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
To Evaluate the Clinical Benefit of NC525 by Assessing Event-free Survival (EFS).
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Time until death, up to 23 monthsPopulation: Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK. The analysis population includes all participants who received at least one dose of NC525 in each dose cohort. All participants were included in the analysis regardless of whether they experienced the event (death). Overall survival was analyzed using the Kaplan-Meier method.
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Outcome measures
| Measure |
9mg/kg NC525
n=9 Participants
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
2mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=2 Participants
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=2 Participants
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
To Evaluate the Clinical Benefit of NC525 by Assessing Overall Survival (OS).
|
4.1 months
Interval 1.1 to 7.7
|
3.8 months
Interval 3.6 to
The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.
|
6 months
Interval 3.1 to
The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.
|
6.5 months
Interval 2.5 to
The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.
|
NA months
Interval 1.5 to
The median overall survival and corresponding upper confidence interval could not be estimated due to the very small sample size and insufficient information to support Kaplan-Meier estimation.
|
3.1 months
Interval 2.6 to
The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to day remission is achieved, up to 23 months (each cycle is 28 days)Population: Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Outcome measures
| Measure |
9mg/kg NC525
n=11 Participants
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
2mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
Assessment of Time to Achieve Response, Defined as CR, CRi, or CRh
|
NA months
Interval 1.8 to
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days)Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis.
To evaluate the maximum observed serum concentration (Cmax) of NC525. The values reported are Cmax at Cycle 2 Day 1.
Outcome measures
| Measure |
9mg/kg NC525
n=9 Participants
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
2mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of NC525
|
268 μg/mL
Standard Deviation 107
|
26.1 μg/mL
Standard Deviation 10.6
|
58.8 μg/mL
Standard Deviation 36.5
|
106 μg/mL
Standard Deviation 16.3
|
445 μg/mL
Standard Deviation 178
|
585 μg/mL
Standard Deviation 176
|
SECONDARY outcome
Timeframe: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reportedPopulation: The PK analysis set includes participants who received NC525 and had sufficient concentration-time data to estimate terminal half-life (t1/2) using noncompartmental analysis. Estimation required an identifiable terminal elimination phase with ≥3 quantifiable post-dose samples. Descriptive statistics were calculated when ≥3 participants had an estimable t1/2. When only 1 participant had an estimable value, the mean is reported and the standard deviation is not calculable.
To evaluate the Terminal Half-life (t1/2) of NC525.
Outcome measures
| Measure |
9mg/kg NC525
n=1 Participants
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
2mg/kg NC525
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=1 Participants
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) of NC525
|
55.3 h
Standard Deviation NA
Standard deviation is not calculable because only one participant had an estimable terminal half-life (t1/2) value in this Arm/Group.
|
—
|
49.8 h
Standard Deviation 19.6
|
—
|
64.2 h
Standard Deviation NA
Standard deviation is not calculable because only one participant had an estimable terminal half-life (t1/2) value in this Arm/Group.
|
—
|
SECONDARY outcome
Timeframe: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reportedPopulation: The PK analysis set includes participants who received NC525 and had sufficient concentration-time data to estimate AUC using noncompartmental analysis for Cycle 1 Day 1. Participants without adequate quantifiable PK samples were excluded for this parameter. Descriptive statistics were calculated when multiple participants had estimable AUC values. When only one participant had an estimable value, the mean is reported and the standard deviation is not calculable.
To evaluate area under the serum concentration versus time curve (AUC) of NC525
Outcome measures
| Measure |
9mg/kg NC525
n=9 Participants
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
2mg/kg NC525
n=1 Participants
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=4 Participants
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=3 Participants
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Versus Time Curve (AUC) of NC525
|
13000 h*μg/mL
Standard Deviation 4480
|
5540 h*μg/mL
Standard Deviation NA
Standard deviation is not calculable because only one participant had an estimable AUC value in this Arm/Group.
|
2180 h*μg/mL
Standard Deviation 755
|
5430 h*μg/mL
Standard Deviation 963
|
23900 h*μg/mL
Standard Deviation 8360
|
33700 h*μg/mL
Standard Deviation 19600
|
Adverse Events
2mg/kg NC525
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
2.5mg/kg NC525
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
4.5mg/kg NC525
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
9mg/kg NC525
Serious events: 9 serious events
Other events: 11 other events
Deaths: 9 deaths
13.5mg/kg NC525
Serious events: 4 serious events
Other events: 4 other events
Deaths: 2 deaths
18mg/kg NC525
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
2mg/kg NC525
n=3 participants at risk
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 participants at risk
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 participants at risk
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
9mg/kg NC525
n=11 participants at risk
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=4 participants at risk
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=3 participants at risk
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
45.5%
5/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Disease progression
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
27.3%
3/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Fatigue
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Pain in extremity
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Differentiation syndrome
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Nervous system disorders
Haemorrhage intracranial
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
Other adverse events
| Measure |
2mg/kg NC525
n=3 participants at risk
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter.
NC525: Monoclonal antibody specific for LAIR-1
|
2.5mg/kg NC525
n=4 participants at risk
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW.
NC525: Monoclonal antibody specific for LAIR-1
|
4.5mg/kg NC525
n=3 participants at risk
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
9mg/kg NC525
n=11 participants at risk
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
13.5mg/kg NC525
n=4 participants at risk
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
18mg/kg NC525
n=3 participants at risk
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing.
NC525: Monoclonal antibody specific for LAIR-1
|
|---|---|---|---|---|---|---|
|
General disorders
Chills
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Face oedema
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Fatigue
|
66.7%
2/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
27.3%
3/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Malaise
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Nodule
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
66.7%
2/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
27.3%
3/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Pain
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Peripheral swelling
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
27.3%
3/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Diverticulitis
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Furuncle
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Rhinovirus infection
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Weight increased
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
75.0%
3/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Injury, poisoning and procedural complications
Vascular access site swelling
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Blood lactic acid increased
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Cardiac disorders
Pericardial effusion
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Ear and labyrinth disorders
Ear congestion
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Eye disorders
Ocular hyperaemia
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
54.5%
6/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Faeces discoloured
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
75.0%
3/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
45.5%
5/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Oral disorder
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
66.7%
2/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
27.3%
3/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
100.0%
3/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
54.5%
6/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
45.5%
5/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
36.4%
4/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Differentiation syndrome
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
27.3%
3/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Nervous system disorders
Haemorrhage intracranial
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
100.0%
4/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
27.3%
3/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
100.0%
3/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
54.5%
6/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
66.7%
2/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
27.3%
3/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
45.5%
5/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
27.3%
3/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
50.0%
2/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
9.1%
1/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
18.2%
2/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
25.0%
1/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
33.3%
1/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
27.3%
3/11 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
75.0%
3/4 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
0.00%
0/3 • From first dose of NC525 through 30 days after the last dose (up to approximately 23 months). For SAEs and ECIs from first dose of NC525 through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the subject initiates new post-treatment cancer therapy, whichever is earlier (up to approximately 23 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI cannot publish study results before the first multi-center publication. If a multi-center publication is not submitted within 12 months after the end of the study at all sites, or if Sponsor confirms there will be no multi-center publication, the PI may publish study results. However, PI will allow Sponsor at least 30 days to review any publication of study results and Sponsor may request an additional 60 days to review the publication.
- Publication restrictions are in place
Restriction type: OTHER