Trial Outcomes & Findings for Indenoisoquinoline LMP744 in Adults With Relapsed Solid Tumors and Lymphomas (NCT NCT03030417)
NCT ID: NCT03030417
Last Updated: 2024-12-10
Results Overview
Maximum tolerated dose (MTD) of LMP744 administered intravenously (IV) daily for 5 days (QD x 5) schedule in participants with refractory solid tumors and lymphomas. The MTD is the dose level at which no more than 1 in 6 participants experience dose-limiting toxicity (DLT), and the dose below that at which ≥ 2 (of ≤ 6) participants have DLT as a result of the drug. A DLT is Grade ≥3 non-hematologic toxicity except Grade 3 fatigue lasting ≤ 7 days. Grade 4 hematological toxicity if it meets the following criteria: Lymphopenia (any grade) will not be considered dose limiting for all participants; Anemia: Grade 4 anemia will be considered dose limiting. Any neurotoxicity Grade ≥2 that is not reversible to a Grade ≤1 within 2 weeks. Any non-hematologic Grade 2 toxicity that does not resolve to Grade ≤1 or baseline within 14 days despite adequate treatment, except for alopecia.
COMPLETED
PHASE1
36 participants
Cycle 1 (28 days)
2024-12-10
Participant Flow
Participant milestones
| Measure |
Treatment (Trmt) Assignment (Assign.) 1: LMP744 (MJ-III65 Hydrochloride) 6mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 6mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 8: LMP744 (MJ-III65 Hydrochloride) 360mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 360mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle. No participants were enrolled in this group.
|
Treatment Assignment 9: LMP744 (MJ-III65 Hydrochloride) 500mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 500mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle. No participants were enrolled in this group.
|
Enrolled But Not Treated
Participant was enrolled but not treated.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation
STARTED
|
1
|
1
|
3
|
1
|
1
|
9
|
0
|
0
|
10
|
1
|
0
|
0
|
0
|
|
Dose Escalation
Restaging
|
1
|
1
|
0
|
1
|
1
|
9
|
0
|
0
|
7
|
1
|
0
|
0
|
0
|
|
Dose Escalation
Pharmacokinetic Sampling
|
1
|
1
|
3
|
1
|
1
|
9
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Tumor Biopsies
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
COMPLETED
|
1
|
1
|
3
|
1
|
1
|
9
|
0
|
0
|
10
|
1
|
0
|
0
|
0
|
|
Dose Escalation
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
5
|
2
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Dose Expansion
Restaging
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
Pharmacokinetic Sampling
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
Tumor Biopsies
|
0
|
0
|
0
|
0
|
0
|
5
|
2
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
5
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Trmt) Assignment (Assign.) 1: LMP744 (MJ-III65 Hydrochloride) 6mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 6mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 8: LMP744 (MJ-III65 Hydrochloride) 360mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 360mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle. No participants were enrolled in this group.
|
Treatment Assignment 9: LMP744 (MJ-III65 Hydrochloride) 500mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 500mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle. No participants were enrolled in this group.
|
Enrolled But Not Treated
Participant was enrolled but not treated.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion
Disease progression before treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Indenoisoquinoline LMP744 in Adults With Relapsed Solid Tumors and Lymphomas
Baseline characteristics by cohort
| Measure |
Treatment (Trmt) Assignment (Assign.) 1: LMP744 (MJ-III65 Hydrochloride) 6mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 6mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=14 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=10 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Enrolled But Not Treated
n=1 Participants
Participant was enrolled but not treated.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 0 • n=5 Participants
|
79 years
STANDARD_DEVIATION 0 • n=7 Participants
|
55.67 years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
81 years
STANDARD_DEVIATION 0 • n=4 Participants
|
39 years
STANDARD_DEVIATION 0 • n=21 Participants
|
62.57 years
STANDARD_DEVIATION 12.18 • n=8 Participants
|
49 years
STANDARD_DEVIATION 19.8 • n=8 Participants
|
46 years
STANDARD_DEVIATION 0 • n=24 Participants
|
61.1 years
STANDARD_DEVIATION 8.96 • n=42 Participants
|
72 years
STANDARD_DEVIATION 0 • n=42 Participants
|
43 years
STANDARD_DEVIATION 0 • n=42 Participants
|
60.03 years
STANDARD_DEVIATION 12.65 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
14 participants
n=8 Participants
|
2 participants
n=8 Participants
|
1 participants
n=24 Participants
|
10 participants
n=42 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
36 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 days)Population: A total of 27/27 participants were analyzed: 27/27 participants who received LMP744 in the Escalation phase were analyzed.
Maximum tolerated dose (MTD) of LMP744 administered intravenously (IV) daily for 5 days (QD x 5) schedule in participants with refractory solid tumors and lymphomas. The MTD is the dose level at which no more than 1 in 6 participants experience dose-limiting toxicity (DLT), and the dose below that at which ≥ 2 (of ≤ 6) participants have DLT as a result of the drug. A DLT is Grade ≥3 non-hematologic toxicity except Grade 3 fatigue lasting ≤ 7 days. Grade 4 hematological toxicity if it meets the following criteria: Lymphopenia (any grade) will not be considered dose limiting for all participants; Anemia: Grade 4 anemia will be considered dose limiting. Any neurotoxicity Grade ≥2 that is not reversible to a Grade ≤1 within 2 weeks. Any non-hematologic Grade 2 toxicity that does not resolve to Grade ≤1 or baseline within 14 days despite adequate treatment, except for alopecia.
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
n=27 Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
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|---|---|---|---|---|---|---|---|---|---|---|
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Dose Escalation Phase: Maximum Tolerated Dose (MTD) of LMP744 (NSC 706744)
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—
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190 mg/m^2
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, prior to drug administration, 2 minutes before end of infusion; 15 minutes, 30 minutes, and 1, 2, 4, and 6 hours post infusion on Day 1 and prior to start of infusion on Day 2.Population: A total of 20/36 participants were analyzed: samples from 20/36 participants who had blood collected for pharmacokinetic analyses were analyzed.
AUC is a measure of the serum concentration of LMP744 over time. It is used to characterize drug absorption.
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
n=1 Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
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Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=9 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
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Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=4 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
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Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
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Dose Escalation & Dose Expansion Phase: Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF) of LMP744 (NSC 706744)
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50.7 ng/mL x h
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37.1 ng/mL x h
|
198 ng/mL x h
Standard Deviation 54
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462 ng/mL x h
|
1858 ng/mL x h
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5752 ng/mL x h
Standard Deviation 5251
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—
|
—
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4928 ng/mL x h
Standard Deviation 2174
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—
|
SECONDARY outcome
Timeframe: Day 1, prior to drug administration, 2 minutes before end of infusion; 15 minutes, 30 minutes, and 1, 2, 4, and 6 hours post infusion on Day 1 and prior to start of infusion on Day 2.Population: A total of 20/36 participants were analyzed: samples from 20/36 participants who had blood collected for pharmacokinetic analyses were analyzed.
Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
n=1 Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=8 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=4 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
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Dose Escalation & Dose Expansion Phase: Apparent Half-Life of LMP744 (NSC 706744)
|
0.52 Hours
|
0.22 Hours
|
3.54 Hours
Standard Deviation 0.91
|
4.66 Hours
|
16.2 Hours
|
12.59 Hours
Standard Deviation 5.11
|
—
|
—
|
5.79 Hours
Standard Deviation 3.30
|
—
|
SECONDARY outcome
Timeframe: Day(D)1, prior to drug administration, 2 minutes (min) before end of infusion; 15 min., 30 min., and 1, 2, 4, and 6 hours (hr) post infusion on D1. 24 hrs post D2, 3, & 4 start of infusion & 2 min. before end of infusion. 72 hrs post D5 start of infusion.Time to maximum (Tmax) concentration of LMP744 (NSC 706744).
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
n=1 Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=14 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=10 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation & Dose Expansion Phase: Time to Maximum (Tmax) Concentration of LMP744 (NSC 706744)
|
1.0 Hours
|
1.0 Hours
|
1.1 Hours
Interval 1.0 to 2.8
|
1.0 Hours
|
1.0 Hours
|
1.0 Hours
Interval 1.0 to 1.0
|
1.0 Hours
Interval 1.0 to 1.0
|
1.0 Hours
|
1.0 Hours
Interval 1.0 to 1.5
|
1.0 Hours
|
SECONDARY outcome
Timeframe: Day(D)1, prior to drug administration, 2 minutes (min) before end of infusion; 15 min., 30 min., and 1, 2, 4, and 6 hours (hr) post infusion on D1. 24 hrs post D2, 3, & 4 start of infusion & 2 min. before end of infusion. 72 hrs post D5 start of infusion.To determine the maximum observed plasma concentration of LMP744, blood samples will be collected from participants and analyzed using a validated liquid chromatography-mass spectrometry (LC-MS) or liquid Chromatography with tandem mass spectrometry (LC-MS-MS) method and calculated by non-compartmental analysis.
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
n=1 Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=14 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=10 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation & Dose Expansion Phase: Maximum Concentration of LMP744 (NSC 706744)
|
69.6 ng/mL
|
48.4 ng/mL
|
78.1 ng/mL
Standard Deviation 49.6
|
446 ng/mL
|
433.1 ng/mL
|
1735.4 ng/mL
Standard Deviation 1188.9
|
861.0 ng/mL
Standard Deviation 108.9
|
839.0 ng/mL
|
1560.9 ng/mL
Standard Deviation 605.5
|
1160.1 ng/mL
|
SECONDARY outcome
Timeframe: Day 1 at end of infusion to Day 5 end of infusion.Population: A total of 20/36 participants were analyzed: samples from 20/36 participants who had blood collected for pharmacokinetic analyses were analyzed.
Percent change in end of infusion drug concentration is a measure of LMP744 (NSC 706744) accumulation in the bloodstream from Day 1 to Day 5.
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
n=1 Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=9 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation & Dose Expansion Phase: Percent Change in End of Infusion Concentration of LMP744 (NSC 706744)
|
33.2 Percent change
|
8.8 Percent change
|
6.9 Percent change
Standard Deviation 35.6
|
20.1 Percent change
|
41.6 Percent change
|
-14.1 Percent change
Standard Deviation 43.0
|
—
|
—
|
25.8 Percent change
Standard Deviation 10.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Tumor re-staging was performed every 2 cycles for the first year on study then every 3 cycles thereafter until a participant met criteria to be removed from the study; a median of 2 cycles completed and a full range of 0-31 cycles completed.Population: A total of 35/36 participants were analyzed: tumor measurements from 35/36 participants who had radiologic imaging were analyzed.
Antitumor activity is evaluated using the rate of confirmed objective responses according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (i.e., at least a 30% decrease in the sum of the diameters of target lesions compared to the sum of baseline diameters).
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
n=1 Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=14 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=10 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation & Dose Expansion Phase: Percentage of Participants With Confirmed Objective Response Following Treatment With LMP744 (NSC 706744)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
50 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment) and Cycle 1 Day 1 at 1-4 hours after the end of the LMP744 (NSC 706744) infusion.Population: A total of 6/36 participants were analyzed: paired biopsy samples from 6 participants in the expansion phase were collected for pharmacodynamic analyses.
Levels of pNbs1 in paired pre-treatment and on-treatment tumor biopsies were quantified in response to treatment with LMP744 (NSC 706744)
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=4 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase: Percent of Nuclear Area Positive (NAP) for Phosphorylated Nibrin (pNbs1) Staining
Pre-Treatment
|
—
|
—
|
—
|
—
|
—
|
1.2 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.7
|
0.2 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.1
|
—
|
—
|
—
|
|
Dose Expansion Phase: Percent of Nuclear Area Positive (NAP) for Phosphorylated Nibrin (pNbs1) Staining
On-Treatment (after end of infusion)
|
—
|
—
|
—
|
—
|
—
|
1.5 Percent of Nuclear Positive Area (NAP)
Standard Deviation 1.0
|
0.4 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.2
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment) and Cycle 1 Day 1 at 1-4 hours after the end of the LMP744 (NSC 706744) infusion.Population: A total of 6/36 participants were analyzed: paired biopsy samples from 6 participants in the expansion phase were collected for pharmacodynamic analyses.
Levels of Rad51 in paired pre-treatment and on-treatment tumor biopsies were quantified in response to treatment with LMP744 (NSC 706744)
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=4 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase: Percent of Nuclear Area Positive (NAP) for RAD Recombinase (Rad51) Staining
Pre-Treatment
|
—
|
—
|
—
|
—
|
—
|
0.2 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.2
|
0.3 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.1
|
—
|
—
|
—
|
|
Dose Expansion Phase: Percent of Nuclear Area Positive (NAP) for RAD Recombinase (Rad51) Staining
On-Treatment (after end of infusion)
|
—
|
—
|
—
|
—
|
—
|
4.3 Percent of Nuclear Positive Area (NAP)
Standard Deviation 2.6
|
3.4 Percent of Nuclear Positive Area (NAP)
Standard Deviation 3.9
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment) and Cycle 1 Day 1 at 1-4 hours after the end of the LMP744 (NSC 706744) infusion.Population: A total of 6/36 participants were analyzed: paired biopsy samples from 6 participants in the expansion phase were collected for pharmacodynamic analyses; one biopsy pair was not quantifiable.
Levels of Top1 in paired pre-treatment and on-treatment tumor biopsies were quantified in response to treatment with LMP744 (NSC 706744)
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase: Percent of Nuclear Area Positive (NAP) for Topoisomerase I (Top1) Staining
Pre-Treatment
|
—
|
—
|
—
|
—
|
—
|
7.0 Percent of Nuclear Positive Area (NAP)
Standard Deviation 3.7
|
2.2 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.1
|
—
|
—
|
—
|
|
Dose Expansion Phase: Percent of Nuclear Area Positive (NAP) for Topoisomerase I (Top1) Staining
On-Treatment (after end of infusion)
|
—
|
—
|
—
|
—
|
—
|
6.4 Percent of Nuclear Positive Area (NAP)
Standard Deviation 4.1
|
1.3 Percent of Nuclear Positive Area (NAP)
Standard Deviation 1.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment) and Cycle 1 Day 1 at 1-4 hours after the end of the LMP744 (NSC 706744) infusion.Population: A total of 6/36 participants were analyzed: paired biopsy samples from 6 participants in the expansion phase were collected for pharmacodynamic analyses.
Levels of pKap1 in paired pre-treatment and on-treatment tumor biopsies were quantified in response to treatment with LMP744 (NSC 706744)
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=4 Samples
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Samples
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase: Percent of Nuclear Area Positive (NAP) for Phosphorylated Krüppel Associated Box (KRAB) Domain-Associated Protein 1 (pKap1) Staining
Pre-Treatment
|
—
|
—
|
—
|
—
|
—
|
0.3 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.1
|
0.5 Percent of Nuclear Positive Area (NAP)
Standard Deviation NA
There were 2 biopsy pairs analyzed, but only 1 was quantifiable, thus standard deviation cannot be determined.
|
—
|
—
|
—
|
|
Dose Expansion Phase: Percent of Nuclear Area Positive (NAP) for Phosphorylated Krüppel Associated Box (KRAB) Domain-Associated Protein 1 (pKap1) Staining
On-Treatment (after end of infusion)
|
—
|
—
|
—
|
—
|
—
|
0.2 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.1
|
0.1 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.2
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment) and Cycle 1 Day 1 at 1-4 hours after the end of the LMP744 (NSC 706744) infusion.Population: A total of 6/36 participants were analyzed: paired biopsy samples from 6 participants in the expansion phase were collected for pharmacodynamic analyses; one biopsy pair was not quantifiable.
Percent of nuclei with ≥19 Top1cc foci in paired pre-treatment and on-treatment tumor biopsies were quantified in response to treatment with LMP744 (NSC 706744)
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase: Percent Change of Nuclei With ≥19 Topoisomerase 1 Cleavage Complex (Top1cc) Foci in Paired Biopsies
Pre-Treatment
|
—
|
—
|
—
|
—
|
—
|
15.4 Percent change
Standard Deviation 14.0
|
7.6 Percent change
Standard Deviation 0.6
|
—
|
—
|
—
|
|
Dose Expansion Phase: Percent Change of Nuclei With ≥19 Topoisomerase 1 Cleavage Complex (Top1cc) Foci in Paired Biopsies
On-Treatment (After end of infusion)
|
—
|
—
|
—
|
—
|
—
|
13.3 Percent change
Standard Deviation 7.6
|
3.2 Percent change
Standard Deviation 4.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment) and Cycle 1 Day 1 at 1-4 hours after the end of the LMP744 (NSC 706744) infusion.Population: A total of 6/36 participants were analyzed: paired biopsy samples from 6 participants in the expansion phase were collected for pharmacodynamic analyses.
Levels of γH2AX in paired pre-treatment and on-treatment tumor biopsies were quantified in response to treatment with LMP744 (NSC 706744)
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=4 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase: Percent of Nuclear Area Positive (NAP) for Phosphorylated Form of Gamma H2A Histone Family Member X (γH2AX) Staining
Pre-Treatment
|
—
|
—
|
—
|
—
|
—
|
0.5 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.1
|
0.4 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.0
|
—
|
—
|
—
|
|
Dose Expansion Phase: Percent of Nuclear Area Positive (NAP) for Phosphorylated Form of Gamma H2A Histone Family Member X (γH2AX) Staining
On-Treatment (after end of infusion)
|
—
|
—
|
—
|
—
|
—
|
0.6 Percent of Nuclear Positive Area (NAP)
Standard Deviation 0.3
|
5.5 Percent of Nuclear Positive Area (NAP)
Standard Deviation 7.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 (28 days)Population: A total of 35/36 participants were analyzed: 35/36 participants who enrolled received at least 1 dose of LMP744 (NSC 706744) and were evaluable for toxicity.
Toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A DLT is Grade ≥3 non-hematologic toxicity except Grade 3 fatigue lasting ≤ 7 days. Grade 4 hematological toxicity if it meets the following criteria: Lymphopenia (any grade) will not be considered dose limiting for all participants; Anemia: Grade 4 anemia will be considered dose limiting. Any neurotoxicity Grade ≥2 that is not reversible to a Grade ≤1 within 2 weeks will be considered dose limiting. Any non-hematologic Grade 2 toxicity that does not resolve to Grade ≤1 or baseline within 14 days despite adequate treatment, except for alopecia. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
n=1 Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=14 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=10 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation & Dose Expansion Phase: Number of Participants With Presence and/or Absence of Grade 2 or Higher Dose Limiting Toxicity (DLT)
Grade 3 DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Dose Escalation & Dose Expansion Phase: Number of Participants With Presence and/or Absence of Grade 2 or Higher Dose Limiting Toxicity (DLT)
Grade 2 DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation & Dose Expansion Phase: Number of Participants With Presence and/or Absence of Grade 2 or Higher Dose Limiting Toxicity (DLT)
Grade 4 DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Dose Escalation & Dose Expansion Phase: Number of Participants With Presence and/or Absence of Grade 2 or Higher Dose Limiting Toxicity (DLT)
Grade 5 DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 (28 days)Population: A total of 35/36 participants were analyzed: 35/36 participants who enrolled received at least 1 dose of LMP744 (NSC 706744) and were evaluable for toxicity.
Toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A DLT is Grade ≥3 non-hematologic toxicity except Grade 3 fatigue lasting ≤ 7 days. Grade 4 hematological toxicity if it meets the following criteria: Lymphopenia (any grade) will not be considered dose limiting for all participants; Anemia: Grade 4 anemia will be considered dose limiting. Any neurotoxicity Grade ≥2 that is not reversible to a Grade ≤1 within 2 weeks will be considered dose limiting. Any non-hematologic Grade 2 toxicity that does not resolve to Grade ≤1 or baseline within 14 days despite adequate treatment, except for alopecia. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
n=1 Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=14 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=10 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation & Dose Expansion Phase: Number of Grades 2, 3, 4 and/or 5 Dose-limiting Toxicities (DLT) by Dose Level
Grade 2 DLT - Weight loss
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
1 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
|
Dose Escalation & Dose Expansion Phase: Number of Grades 2, 3, 4 and/or 5 Dose-limiting Toxicities (DLT) by Dose Level
Grade 3 DLT - Hypokalemia
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
1 toxicities
|
0 toxicities
|
0 toxicities
|
6 toxicities
|
0 toxicities
|
|
Dose Escalation & Dose Expansion Phase: Number of Grades 2, 3, 4 and/or 5 Dose-limiting Toxicities (DLT) by Dose Level
Grade 3 DLT - Anemia
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
1 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
|
Dose Escalation & Dose Expansion Phase: Number of Grades 2, 3, 4 and/or 5 Dose-limiting Toxicities (DLT) by Dose Level
Grade 5 DLT - Death
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
0 toxicities
|
1 toxicities
|
0 toxicities
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.Population: A total of 35/36 participants were analyzed: 35/36 participants who enrolled received at least 1 dose of LMP744 (NSC 706744) and were evaluable for toxicity.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
All Participants
n=1 Participants
Dose Escalation: All participants who received LMP744 at Treatment Assignment 1 (6 mg/m\^2), Treatment Assignment 2 (12 mg/m\^2), Treatment Assignment 3 (24 mg/m\^2), Treatment Assignment 4 (48 mg/m\^2), Treatment Assignment 5 (96 mg/m\^2), Treatment Assignment 6 (190 mg/m\^2), n=9/14, Treatment Assignment 7 (260 mg/m\^2), and Treatment Assignment 7 (260 mg/m\^2) followed by Treatment Assignment 6 (190 mg/m\^2) were assessed for dose-limiting toxicities.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=14 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=10 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
n=1 Participants
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation & Dose Expansion Phase: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
14 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
1 Participants
|
Adverse Events
Treatment (Trmt) Assignment (Assign.) 1: LMP744 (MJ-III65 Hydrochloride) 6mg/m^2
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
Serious adverse events
| Measure |
Treatment (Trmt) Assignment (Assign.) 1: LMP744 (MJ-III65 Hydrochloride) 6mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 6mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=14 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=10 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
21.4%
3/14 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
GGT increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Infections and infestations
Infections and infestations - Other, Bacteremia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Infections and infestations
Infections and infestations - Other, Sepsis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Multi-organ failure
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Disease Progession
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Pain
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Sudden death NOS
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
White blood cell decreased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Esophageal obstruction
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Death
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Fever
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
Other adverse events
| Measure |
Treatment (Trmt) Assignment (Assign.) 1: LMP744 (MJ-III65 Hydrochloride) 6mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 6mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 2: LMP744 (MJ-III65 Hydrochloride) 12mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 12mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 3: LMP744 (MJ-III65 Hydrochloride) 24mg/m^2
n=3 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 24mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 4: LMP744 (MJ-III65 Hydrochloride) 48mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 5: LMP744 (MJ-III65 Hydrochloride) 96mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2
n=14 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 6: LMP744 (MJ-III65 Hydrochloride) 190mg/m^2 Followed by Trmt Assign. 5: 96mg/m^2
n=2 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assign. 6:LMP744 190mg/m^2 Foll. by Trmt Assign. 5: 96mg/m^2 Foll. by Trmt Assign. 4: 48mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 190mg/m\^2 intravenous over 1 hour on days 1-5 followed by 96mg/m\^2 intravenous over 1 hour on days 1-5 followed by 48mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Treatment Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2
n=10 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
Trmt Assignment 7: LMP744 (MJ-III65 Hydrochloride) 260mg/m^2 Followed by Trmt Assign. 6: 190mg/m^2
n=1 participants at risk
Participants with metastatic solid tumors that have progressed after one line of therapy, or lymphoma that has progressed after all therapy. LMP744 (MJ-III65 hydrochloride) 260mg/m\^2 intravenous over 1 hour on days 1-5 followed by 190mg/m\^2 intravenous over 1 hour on days 1-5 of each 28 day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
TSH increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
7/14 • Number of events 17 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 5 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
35.7%
5/14 • Number of events 5 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
71.4%
10/14 • Number of events 14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 8 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 13 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
21.4%
3/14 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
30.0%
3/10 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
35.7%
5/14 • Number of events 8 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
35.7%
5/14 • Number of events 8 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
66.7%
2/3 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
71.4%
10/14 • Number of events 21 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 8 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
80.0%
8/10 • Number of events 16 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
66.7%
2/3 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
42.9%
6/14 • Number of events 7 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 5 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
66.7%
2/3 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
7/14 • Number of events 14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
5/10 • Number of events 5 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, Anemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, blood bilirubin increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 7 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
28.6%
4/14 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Cardiac disorders
Cardiac disorders - Other, Left Ventricular wall hypokinesis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Eye disorders
Cataract
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Chills
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
30.0%
3/10 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
7/14 • Number of events 10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Creatinine increased
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
42.9%
6/14 • Number of events 11 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 5 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
70.0%
7/10 • Number of events 8 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
7/14 • Number of events 10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
30.0%
3/10 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Edema limbs
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
21.4%
3/14 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Endocrine disorders
Endocrine disorders - Other, Hypothyroid
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Endocrine disorders
Endocrine disorders - Other, TSH decrease
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Endocrine disorders
Endocrine disorders - Other, TSH increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Eye disorders
Eye disorders - Other, Ptosis-R side
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
57.1%
8/14 • Number of events 9 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
5/10 • Number of events 5 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Fever
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
GGT increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
42.9%
6/14 • Number of events 16 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 6 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Abdominal cramping
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Early satiety
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Hematemesis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Nausea
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
General disorders and administration site conditions - Other, LEFT SIDED PAIN
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
42.9%
6/14 • Number of events 9 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
35.7%
5/14 • Number of events 6 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
78.6%
11/14 • Number of events 20 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 6 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
80.0%
8/10 • Number of events 11 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 6 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
42.9%
6/14 • Number of events 18 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
70.0%
7/10 • Number of events 13 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
66.7%
2/3 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
57.1%
8/14 • Number of events 19 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
60.0%
6/10 • Number of events 15 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
21.4%
3/14 • Number of events 6 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
42.9%
6/14 • Number of events 26 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
5/10 • Number of events 5 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
71.4%
10/14 • Number of events 28 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 6 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
60.0%
6/10 • Number of events 11 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Infections and infestations
Infections and infestations - Other, Bacteremia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Investigations - Other, Back Spasms
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Investigations - Other, Weight Loss
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Investigations - Other, Discoloration right toe nail
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 6 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Investigations - Other, Chloestatic Pruritus
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Investigations - Other, Eosinophilia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Investigations - Other, Generalized edema
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Investigations - Other, Hyponatremia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Investigations - Other, TSH increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Investigations - Other, INR increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
66.7%
2/3 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 7 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
71.4%
10/14 • Number of events 21 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 15 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
80.0%
8/10 • Number of events 18 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Malaise
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Anorexia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Dehydration
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Hyperphosphatemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Hyponatremia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Muscle Cramp
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Nasal congestion
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
71.4%
10/14 • Number of events 22 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 6 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
28.6%
4/14 • Number of events 5 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
General disorders
Pain
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
30.0%
3/10 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Nervous system disorders
Paresthesia
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Eye disorders
Photophobia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
35.7%
5/14 • Number of events 13 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 5 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
57.1%
8/14 • Number of events 20 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Lactate dehydrogenase increased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Dysuria
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Glucosuria
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, P/C ratio inc
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, Pulmonic Insufficiency
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Pulmonic insufficiency
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 5 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Discoloration R toe nail
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, possibly sunburn
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Folliculitis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Intercostal incisional hernia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Psoriasis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Skin discoloration - Face
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Rash Poss sunburn
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Pain, biopsy site
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
7/14 • Number of events 16 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 6 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
Weight loss
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
42.9%
6/14 • Number of events 13 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 6 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Investigations
White blood cell decreased
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
35.7%
5/14 • Number of events 14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
2/2 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
30.0%
3/10 • Number of events 8 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Cardiac disorders
Cardiac disorders - Other, Pulmonic Insufficiency
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
20.0%
2/10 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
33.3%
1/3 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
100.0%
1/1 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
40.0%
4/10 • Number of events 4 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Renal and urinary disorders
Glucosuria
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
14.3%
2/14 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
30.0%
3/10 • Number of events 3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Discoloration R toe
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
7.1%
1/14 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/2 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/10 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/3 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/14 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
50.0%
1/2 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
10.0%
1/10 • Number of events 1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
0.00%
0/1 • From first drug administration through 30 days after the last dose of study drug is administered, an average of 12.9 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place