Trial Outcomes & Findings for A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors (NCT NCT03665285)
NCT ID: NCT03665285
Last Updated: 2024-03-08
Results Overview
The number of participants who have had at least one TEAE during the study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
109 participants
Primary outcome timeframe
From enrollment through up to 90 days after end of treatment, an average of 1 year
Results posted on
2024-03-08
Participant Flow
109 participants took part in the study at 6 investigative sites in the United States from 01 October 2018 to 11 April 2023.
The dose-escalation consisted of 7 planned cohorts (NC318 IV doses of 8 mg to 1600 mg). Phase 1b was a safety expansion of 3 cohorts (80 mg, 240 mg, and 400 mg). 49 participants were enrolled in Phase 1. A RP2D of 400 mg Q2W was initially evaluated in Phase 2 (N=47); an alternative RP2D of 800 mg weekly for 8 cycles, followed by 800 mg Q2W thereafter (N=13) was also evaluated.
Participant milestones
| Measure |
NC318 8mg
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
10
|
12
|
11
|
4
|
4
|
47
|
13
|
|
Overall Study
COMPLETED
|
3
|
3
|
5
|
7
|
9
|
3
|
2
|
19
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
5
|
5
|
2
|
1
|
2
|
28
|
2
|
Reasons for withdrawal
| Measure |
NC318 8mg
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Started New Anticancer Treatment
|
1
|
1
|
2
|
4
|
1
|
1
|
2
|
15
|
1
|
|
Overall Study
Disease Progression
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
7
|
1
|
|
Overall Study
Hospice
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
NC318 8mg
n=4 Participants
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
n=47 Participants
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
n=13 Participants
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
23 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
58 Participants
n=62 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
24 Participants
n=40 Participants
|
8 Participants
n=8 Participants
|
51 Participants
n=62 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
30 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
65 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
17 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
44 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
15 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
41 Participants
n=40 Participants
|
10 Participants
n=8 Participants
|
92 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
35 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
86 Participants
n=62 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=62 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
4 participants
n=4 Participants
|
10 participants
n=27 Participants
|
12 participants
n=483 Participants
|
11 participants
n=36 Participants
|
4 participants
n=10 Participants
|
4 participants
n=115 Participants
|
47 participants
n=40 Participants
|
13 participants
n=8 Participants
|
109 participants
n=62 Participants
|
PRIMARY outcome
Timeframe: From enrollment through up to 90 days after end of treatment, an average of 1 yearPopulation: The Safety Analysis Set (SAS) will include all the subjects who receive any amount of study drug.
The number of participants who have had at least one TEAE during the study.
Outcome measures
| Measure |
NC318 8mg
n=4 Participants
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
n=47 Participants
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
n=13 Participants
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
|
4 Participants
|
4 Participants
|
10 Participants
|
12 Participants
|
11 Participants
|
4 Participants
|
4 Participants
|
45 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.
To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Outcome measures
| Measure |
NC318 8mg
n=4 Participants
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
n=47 Participants
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
n=13 Participants
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.
To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
NC318 8mg
n=4 Participants
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
n=47 Participants
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
n=13 Participants
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
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.
|
NA months
Insufficient number of participants with events.
|
8.11 months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.
To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Outcome measures
| Measure |
NC318 8mg
n=4 Participants
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
n=47 Participants
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
n=13 Participants
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
3 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
14 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.
To evaluate progression-free survival (PFS), defined as the time from the first dose of NC318 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
NC318 8mg
n=4 Participants
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
n=47 Participants
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
n=13 Participants
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
NA months
Interval 2.82 to
The median and upper limit of the confidence interval were not estimable due to limited number of participants with events.
|
1.32 months
Interval 0.97 to
The upper limit of the confidence interval was not estimable due to limited number of participants with events.
|
5.72 months
Interval 1.47 to 10.0
|
1.86 months
Interval 1.1 to
The upper limit of the confidence interval was not estimable due to limited number of participants with events.
|
2.54 months
Interval 1.82 to 5.14
|
3.93 months
Interval 1.79 to
The upper limit of the confidence interval was not estimable due to limited number of participants with events.
|
3.29 months
Interval 0.54 to
The upper limit of the confidence interval was not estimable due to limited number of participants with events.
|
2.04 months
Interval 1.82 to 2.25
|
1.79 months
Interval 0.79 to 1.97
|
SECONDARY outcome
Timeframe: Approximately 1 yearPopulation: The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.
To evaluate overall survival (OS), defined as the time from the first dose of NC318 to death due to any cause.
Outcome measures
| Measure |
NC318 8mg
n=4 Participants
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
n=47 Participants
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
n=13 Participants
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA months
The median and confidence intervals were not estimable due to limited number of participants with event.
|
NA months
Interval 1.71 to
The median and upper limit of the confidence interval were not estimable due to limited number of participants with event.
|
NA months
The median and confidence intervals were not estimable due to limited number of participants with event.
|
11.04 months
Interval 1.54 to
The upper limit of the confidence interval was not estimable due to limited number of participants with event.
|
6.18 months
Interval 3.25 to
The upper limit of the confidence interval was not estimable due to limited number of participants with event.
|
NA months
Interval 4.07 to
The median and upper limit of the confidence interval were not estimable due to limited number of participants with event.
|
NA months
Interval 1.28 to
The median and upper limit of the confidence interval were not estimable due to limited number of participants with event.
|
NA months
The median and confidence intervals were not estimable due to limited number of participants with event.
|
3.55 months
Interval 0.95 to
The upper limit of the confidence interval was not estimable due to limited number of participants with event.
|
SECONDARY outcome
Timeframe: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. PK analysis only took place during the dose escalation portion of the study.
To evaluate the Maximum Plasma Concentration (Cmax) of NC318
Outcome measures
| Measure |
NC318 8mg
n=4 Participants
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of NC318
|
3010 ng/mL
Standard Deviation 2194
|
5020 ng/mL
Standard Deviation 774
|
17130 ng/mL
Standard Deviation 5120
|
55025 ng/mL
Standard Deviation 12393
|
97816 ng/mL
Standard Deviation 19174
|
352500 ng/mL
Standard Deviation 310095
|
329750 ng/mL
Standard Deviation 99399
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. PK analysis only took place during the dose escalation portion of the study.
To evaluate the Area Under the Curve (AUC) of NC318
Outcome measures
| Measure |
NC318 8mg
n=4 Participants
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC) of NC318
|
171933 h*ng/mL
Standard Deviation NA
SD was below the lower limit of detection.
|
112327 h*ng/mL
Standard Deviation NA
SD was below the lower limit of detection.
|
290486 h*ng/mL
Standard Deviation 115984
|
724225 h*ng/mL
Standard Deviation 538755
|
1324013 h*ng/mL
Standard Deviation 688403
|
4335767 h*ng/mL
Standard Deviation 2288217
|
9837043 h*ng/mL
Standard Deviation 5163985
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, and 3 of Cycles 1 and 5 and Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 21. Each cycle is 7 days during Cycles 1-8 and 14 days thereafter.Population: The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. PK analysis only took place during the dose escalation portion of the study.
To evaluate the half-life (t1/2) of NC318
Outcome measures
| Measure |
NC318 8mg
n=4 Participants
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 Participants
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 Participants
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Half-life (t1/2) of NC318
|
46.16 hours
Standard Deviation NA
SD was below lower limit of detection.
|
24.62 hours
Standard Deviation NA
SD was below lower limit of detection.
|
46.41 hours
Standard Deviation 10.68
|
34.81 hours
Standard Deviation 13.15
|
32.25 hours
Standard Deviation 10.37
|
32.67 hours
Standard Deviation 6.57
|
32.71 hours
Standard Deviation 6.0
|
—
|
—
|
Adverse Events
NC318 8mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
NC318 24mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
NC318 80mg
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
NC318 240mg
Serious events: 8 serious events
Other events: 12 other events
Deaths: 4 deaths
NC318 400mg
Serious events: 4 serious events
Other events: 10 other events
Deaths: 3 deaths
NC318 800mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
NC318 1600mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Expansion: 400mg Q2W
Serious events: 16 serious events
Other events: 42 other events
Deaths: 7 deaths
Dose Expansion: 800mg QW
Serious events: 5 serious events
Other events: 12 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
NC318 8mg
n=4 participants at risk
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 participants at risk
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 participants at risk
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 participants at risk
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 participants at risk
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 participants at risk
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 participants at risk
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
n=47 participants at risk
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
n=13 participants at risk
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Death nos
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Disease Progression
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Osteomyelitis
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Product Issues
Device occlusion
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
Other adverse events
| Measure |
NC318 8mg
n=4 participants at risk
Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 24mg
n=4 participants at risk
Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 80mg
n=10 participants at risk
Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 240mg
n=12 participants at risk
Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 400mg
n=11 participants at risk
Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 800mg
n=4 participants at risk
Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
NC318 1600mg
n=4 participants at risk
Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 400mg Q2W
n=47 participants at risk
Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
Dose Expansion: 800mg QW
n=13 participants at risk
Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Abdominal pain UPPER
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
30.0%
3/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
3/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
36.4%
4/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
12.8%
6/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
30.8%
4/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
20.0%
2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
50.0%
2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
20.0%
2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
27.3%
3/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
12.8%
6/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
40.0%
4/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
3/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.5%
4/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
15.4%
2/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
50.0%
2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
40.0%
4/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
3/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
6.4%
3/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
40.0%
4/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
3/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
27.3%
3/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
17.0%
8/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
23.1%
3/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
3/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
19.1%
9/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
30.8%
4/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Chest pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Chills
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
27.3%
3/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
12.8%
6/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Face oedema
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Fatigue
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
40.0%
4/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.5%
12/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
15.4%
2/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
6.4%
3/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.5%
4/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
3/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
6.4%
3/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Supraclavicular fossa pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
General disorders
Swelling
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
COVID-19
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Chorioretinitis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Cystitis
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Gingivitis
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Osteomyelitis
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Tooth infection
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
14.9%
7/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
20.0%
2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
15.4%
2/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.5%
4/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
15.4%
2/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
3/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
15.4%
2/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
15.4%
2/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Blood calcium increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Blood creatine increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
15.4%
2/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
20.0%
2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
15.4%
2/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Investigations
Weight increased
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
14.9%
7/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
15.4%
2/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
50.0%
2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
50.0%
2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
6.4%
3/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
27.3%
3/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
50.0%
2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
6.4%
3/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
23.1%
3/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
6.4%
3/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.6%
5/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
15.4%
2/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
20.0%
2/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.5%
4/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.5%
4/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Burning sensation
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
30.0%
3/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.6%
5/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Dysaesthesia
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Fine motor skill dysfunction
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
50.0%
2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
50.0%
2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.5%
4/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Renal and urinary disorders
Pollakiuria
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.5%
4/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
17.0%
8/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
16.7%
2/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.5%
4/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
40.0%
4/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
18.2%
2/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.6%
5/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
50.0%
2/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
9.1%
1/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
6.4%
3/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
8.3%
1/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
25.0%
1/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
2.1%
1/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
10.0%
1/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
4.3%
2/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/10 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/12 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/11 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/4 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
0.00%
0/47 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
7.7%
1/13 • From enrollment through up to 90 days after end of treatment, an average of 1 year
The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.
|
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