Trial Outcomes & Findings for Pazopanib and ARQ 197 for Advanced Solid Tumors (NCT NCT01468922)
NCT ID: NCT01468922
Last Updated: 2022-07-01
Results Overview
The highest Grade 3 or 4 adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is severe, and Grade 4 is life threatening.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Time receiving study drug, up to 22 cycles
Results posted on
2022-07-01
Participant Flow
Participant milestones
| Measure |
Dose Level (DL) 1: Pazopanib (Paz): 400 mg & ARQ 197 (Tivantinib): 120 mg
Cycle=28 days,Pazopanib: 400 mg by mouth (PO) every day (QD) ,ARQ 197: 120 mg PO twice a day (BID)
|
Dose Level 2: Pazopanib: 600 mg & ARQ 197: 120 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 3: Pazopanib: 600 mg & ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 3 Followed by DL 2: Pazopanib: 600 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197:120 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 4: Pazopanib: 800 mg & ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 4 Followed by DL 3: Pazopanib: 800 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL4 Foll/by DL3 Foll/by DL2 Paz800mg/ARQ240mg Foll/by Paz600 mg/ARQ240mg Foll/by Paz600 mg/ARQ120 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 5: Pazopanib: 800 mg & ARQ 197: 360 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 360 mg by mouth (PO) twice a day (BID)
|
Enrolled But Not Treated
Enrolled but failed screening and was not treated.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
2
|
1
|
4
|
1
|
1
|
16
|
1
|
|
Overall Study
COMPLETED
|
1
|
3
|
2
|
1
|
2
|
1
|
1
|
12
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
2
|
0
|
0
|
4
|
1
|
Reasons for withdrawal
| Measure |
Dose Level (DL) 1: Pazopanib (Paz): 400 mg & ARQ 197 (Tivantinib): 120 mg
Cycle=28 days,Pazopanib: 400 mg by mouth (PO) every day (QD) ,ARQ 197: 120 mg PO twice a day (BID)
|
Dose Level 2: Pazopanib: 600 mg & ARQ 197: 120 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 3: Pazopanib: 600 mg & ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 3 Followed by DL 2: Pazopanib: 600 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197:120 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 4: Pazopanib: 800 mg & ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 4 Followed by DL 3: Pazopanib: 800 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL4 Foll/by DL3 Foll/by DL2 Paz800mg/ARQ240mg Foll/by Paz600 mg/ARQ240mg Foll/by Paz600 mg/ARQ120 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 5: Pazopanib: 800 mg & ARQ 197: 360 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 360 mg by mouth (PO) twice a day (BID)
|
Enrolled But Not Treated
Enrolled but failed screening and was not treated.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Screening failure
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Per patient choice
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Switched to alternative treatment
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Enrolled on new protocol
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Infection of blood
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Patient choice - surgery
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Refused further treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pazopanib and ARQ 197 for Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Level (DL) 1: Pazopanib (Paz): 400 mg & ARQ 197: 120 mg
n=3 Participants
Cycle=28 days,Pazopanib: 400 mg by mouth (PO) every day (QD) ,ARQ 197: 120 mg PO twice a day (BID)
|
Dose Level 2: Pazopanib: 600 mg & ARQ 197: 120 mg
n=3 Participants
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 3: Pazopanib: 600 mg & ARQ 197: 240 mg
n=2 Participants
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 3 Followed by DL 2: Pazopanib: 600 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197:120 mg
n=1 Participants
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 4: Pazopanib: 800 mg & ARQ 197: 240 mg
n=4 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 4 Followed by DL 3: Pazopanib: 800 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197: 240 mg
n=1 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL4 Foll/by DL3 Foll/by DL2 Paz800mg/ARQ240mg Foll/by Paz600 mg/ARQ240mg Foll/by Paz600 mg/ARQ120 mg
n=1 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 5: Pazopanib: 800 mg & ARQ 197: 360 mg
n=16 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 360 mg by mouth (PO) twice a day (BID)
|
Enrolled But Not Treated
n=1 Participants
Enrolled but failed screening and was not treated.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 23.95 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 11.92 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 7.21 • n=5 Participants
|
27.6 years
STANDARD_DEVIATION 0 • n=4 Participants
|
56.38 years
STANDARD_DEVIATION 8.42 • n=21 Participants
|
20.5 years
STANDARD_DEVIATION 0 • n=8 Participants
|
61.9 years
STANDARD_DEVIATION 0 • n=8 Participants
|
50.04 years
STANDARD_DEVIATION 13.45 • n=24 Participants
|
44.4 years
STANDARD_DEVIATION 0 • n=42 Participants
|
49.25 years
STANDARD_DEVIATION 14.56 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
14 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
28 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
20 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
16 participants
n=24 Participants
|
1 participants
n=42 Participants
|
32 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Time receiving study drug, up to 22 cyclesThe highest Grade 3 or 4 adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is severe, and Grade 4 is life threatening.
Outcome measures
| Measure |
Dose Level (DL) 1: Pazopanib (Paz): 400 mg & ARQ 197: 120 mg
n=3 Participants
Cycle=28 days,Pazopanib: 400 mg by mouth (PO) every day (QD) ,ARQ 197: 120 mg PO twice a day (BID)
|
Dose Level 2: Pazopanib: 600 mg & ARQ 197: 120 mg
n=3 Participants
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 3: Pazopanib: 600 mg & ARQ 197: 240 mg
n=2 Participants
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 3 Followed by DL 2: Pazopanib: 600 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197:120 mg
n=1 Participants
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 4: Pazopanib: 800 mg & ARQ 197: 240 mg
n=4 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 4 Followed by DL 3: Pazopanib: 800 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197: 240 mg
n=1 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL4 Foll/by DL3 Foll/by DL2 Paz800mg/ARQ240mg Foll/by Paz600 mg/ARQ240mg Foll/by Paz600 mg/ARQ120 mg
n=1 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 5: Pazopanib: 800 mg & ARQ 197: 360 mg
n=16 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 360 mg by mouth (PO) twice a day (BID)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Grade 3 or 4 Adverse Events, Highest Occurrence Per Participant
Grade 3
|
1 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
3 Adverse events
|
5 Adverse events
|
1 Adverse events
|
7 Adverse events
|
|
Number of Grade 3 or 4 Adverse Events, Highest Occurrence Per Participant
Grade 4
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
0 Adverse events
|
1 Adverse events
|
10 Adverse events
|
PRIMARY outcome
Timeframe: MET and phospho-MET levels were measured on Cycle 1 Day 1 and Cycle 1 Day 8.Population: Biopsies were not collected for this assay from all participants, and not all biopsies yielded quantifiable data. While biopsies were collected from 8 patients at Dose Level 5, not every biopsy pair yielded a quantifiable signal in these assays. There were 5 pairs averaged for the intact MET and 2 pairs each for the pY1234/1235-MET and pY1356-MET. Unquantifiable biopsy pairs (either at one or both time points) were excluded from the analysis.
MET or phospho-MET levels (in fmol) normalized to the amount of total protein in a sample (in mg).
Outcome measures
| Measure |
Dose Level (DL) 1: Pazopanib (Paz): 400 mg & ARQ 197: 120 mg
n=1 Collected biopsy pairs
Cycle=28 days,Pazopanib: 400 mg by mouth (PO) every day (QD) ,ARQ 197: 120 mg PO twice a day (BID)
|
Dose Level 2: Pazopanib: 600 mg & ARQ 197: 120 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 3: Pazopanib: 600 mg & ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 3 Followed by DL 2: Pazopanib: 600 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197:120 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 4: Pazopanib: 800 mg & ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 4 Followed by DL 3: Pazopanib: 800 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL4 Foll/by DL3 Foll/by DL2 Paz800mg/ARQ240mg Foll/by Paz600 mg/ARQ240mg Foll/by Paz600 mg/ARQ120 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 5: Pazopanib: 800 mg & ARQ 197: 360 mg
n=8 Collected biopsy pairs
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 360 mg by mouth (PO) twice a day (BID)
|
|---|---|---|---|---|---|---|---|---|
|
Changes in MET and Phospho-MET Levels
Intact MET
|
-52.66 fmol/mg
Standard Deviation NA
Not all biopsies yielded quantifiable data. Standard deviation was not calculated because only 1 biopsy pair was analyzed; calculating standard deviation requires at least 2 measured values.
|
—
|
—
|
—
|
—
|
—
|
—
|
-195.4 fmol/mg
Standard Deviation 218.9
|
|
Changes in MET and Phospho-MET Levels
pY1234/1235-MET
|
NA fmol/mg
Not all biopsies yielded quantifiable data. No biopsy pairs yielded quantifiable data for pY1234/1235-MET.
|
—
|
—
|
—
|
—
|
—
|
—
|
-130.3 fmol/mg
Standard Deviation 40.2
|
|
Changes in MET and Phospho-MET Levels
pY1356-MET
|
NA fmol/mg
Not all biopsies yielded quantifiable data. No biopsy pairs yielded quantifiable data for pY1234/1235-MET.
|
—
|
—
|
—
|
—
|
—
|
—
|
-51.5 fmol/mg
Standard Deviation 1.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approx 22m (month)/2 days(d); 13m/20 d; 5m/23 d; 17m./24 d; 7 m/5 d; 5m/5 d; 5m/13 d; and 23m/21d for DL1, DL2, DL3, DL3 foll/by DL2, DL4, DL4 foll/by DL3, DL 4 foll/by DL 3 foll/by DL2; & DL5 respectively.Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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 |
Dose Level (DL) 1: Pazopanib (Paz): 400 mg & ARQ 197: 120 mg
n=3 Participants
Cycle=28 days,Pazopanib: 400 mg by mouth (PO) every day (QD) ,ARQ 197: 120 mg PO twice a day (BID)
|
Dose Level 2: Pazopanib: 600 mg & ARQ 197: 120 mg
n=3 Participants
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 3: Pazopanib: 600 mg & ARQ 197: 240 mg
n=2 Participants
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 3 Followed by DL 2: Pazopanib: 600 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197:120 mg
n=1 Participants
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 4: Pazopanib: 800 mg & ARQ 197: 240 mg
n=4 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 4 Followed by DL 3: Pazopanib: 800 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197: 240 mg
n=1 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL4 Foll/by DL3 Foll/by DL2 Paz800mg/ARQ240mg Foll/by Paz600 mg/ARQ240mg Foll/by Paz600 mg/ARQ120 mg
n=1 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 5: Pazopanib: 800 mg & ARQ 197: 360 mg
n=16 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 360 mg by mouth (PO) twice a day (BID)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and day 8 post administrationPopulation: This analysis was only performed on biopsy pairs from participants at Dose Level 5, so no biopsy pairs were collected at other Dose Levels (which is why the other levels indicate 0 participants analyzed) and analysis of the changes at those Dose Levels was not applicable (N/A) since no samples were collected.
Core tumor biopsies were collected from participants with advanced malignancies. Analyses was performed by epithelial-mesenchymal transition immunofluorescence assay (EMT-IFA) for changes in E-cadherin (E+), vimentin(V+), and mixed V+E+ phenotypes. The small imaging pixel size (0.25 µm\^2)of the IFA relative to the dimensions of the cross sectional areas of tumor (ranging from 75 to 500 µm\^2 in parotid, prostate, colon, and ovarian cancers) allowed us to quantify individual areas of V+ and E+ staining as well as areas of colocalized E+V+ staining within single cells. The assay reports the change in log10(V/E) vratios. The log10(V/E) ratio was determined pre-treatment and in day 8 biopsies and the reported values indicate the change between the two time points. Each value in the table as currently written reflects the change in log10(V/E) ratios between pre- and post-treatment E-cadherin and vimentin values. The full range values indicate the range of changes observed for individual pt.
Outcome measures
| Measure |
Dose Level (DL) 1: Pazopanib (Paz): 400 mg & ARQ 197: 120 mg
Cycle=28 days,Pazopanib: 400 mg by mouth (PO) every day (QD) ,ARQ 197: 120 mg PO twice a day (BID)
|
Dose Level 2: Pazopanib: 600 mg & ARQ 197: 120 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 3: Pazopanib: 600 mg & ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 3 Followed by DL 2: Pazopanib: 600 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197:120 mg
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 4: Pazopanib: 800 mg & ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 4 Followed by DL 3: Pazopanib: 800 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197: 240 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL4 Foll/by DL3 Foll/by DL2 Paz800mg/ARQ240mg Foll/by Paz600 mg/ARQ240mg Foll/by Paz600 mg/ARQ120 mg
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 5: Pazopanib: 800 mg & ARQ 197: 360 mg
n=7 Participants
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 360 mg by mouth (PO) twice a day (BID)
|
|---|---|---|---|---|---|---|---|---|
|
Pazopanib-induced Changes to Epithelial-mesenchymal Phenotype in Human Tumors
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.332 Change in log10(V/E) Ratios
Interval -0.126 to 0.723
|
Adverse Events
Dose Level (DL) 1: Pazopanib (Paz): 400 mg & ARQ 197: 120 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 2: Pazopanib: 600 mg & ARQ 197: 120 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 3: Pazopanib: 600 mg & ARQ 197: 240 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
DL 3 Followed by DL 2: Pazopanib: 600 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197:120 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 4: Pazopanib: 800 mg & ARQ 197: 240 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
DL 4 Followed by DL 3: Pazopanib: 800 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197: 240 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DL4 Foll/by DL3 Foll/by DL2 Paz800mg/ARQ240mg Foll/by Paz600 mg/ARQ240mg Foll/by Paz600 mg/ARQ120 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 5: Pazopanib: 800 mg & ARQ 197: 360 mg
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level (DL) 1: Pazopanib (Paz): 400 mg & ARQ 197: 120 mg
n=3 participants at risk
Cycle=28 days,Pazopanib: 400 mg by mouth (PO) every day (QD) ,ARQ 197: 120 mg PO twice a day (BID)
|
Dose Level 2: Pazopanib: 600 mg & ARQ 197: 120 mg
n=3 participants at risk
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 3: Pazopanib: 600 mg & ARQ 197: 240 mg
n=2 participants at risk
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 3 Followed by DL 2: Pazopanib: 600 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197:120 mg
n=1 participants at risk
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 4: Pazopanib: 800 mg & ARQ 197: 240 mg
n=4 participants at risk
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 4 Followed by DL 3: Pazopanib: 800 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197: 240 mg
n=1 participants at risk
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL4 Foll/by DL3 Foll/by DL2 Paz800mg/ARQ240mg Foll/by Paz600 mg/ARQ240mg Foll/by Paz600 mg/ARQ120 mg
n=1 participants at risk
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 5: Pazopanib: 800 mg & ARQ 197: 360 mg
n=16 participants at risk
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 360 mg by mouth (PO) twice a day (BID)
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Psychiatric disorders
Confusion
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Enterocolitis infectious
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Febrile neutropenia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
General disorders
Fever
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
General disorders
Malaise
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, progressive disease
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
Other adverse events
| Measure |
Dose Level (DL) 1: Pazopanib (Paz): 400 mg & ARQ 197: 120 mg
n=3 participants at risk
Cycle=28 days,Pazopanib: 400 mg by mouth (PO) every day (QD) ,ARQ 197: 120 mg PO twice a day (BID)
|
Dose Level 2: Pazopanib: 600 mg & ARQ 197: 120 mg
n=3 participants at risk
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 3: Pazopanib: 600 mg & ARQ 197: 240 mg
n=2 participants at risk
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 3 Followed by DL 2: Pazopanib: 600 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197:120 mg
n=1 participants at risk
Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 4: Pazopanib: 800 mg & ARQ 197: 240 mg
n=4 participants at risk
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL 4 Followed by DL 3: Pazopanib: 800 mg & ARQ 197: 240 mg Foll/by Pazopanib: 600 mg/ARQ 197: 240 mg
n=1 participants at risk
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID)
|
DL4 Foll/by DL3 Foll/by DL2 Paz800mg/ARQ240mg Foll/by Paz600 mg/ARQ240mg Foll/by Paz600 mg/ARQ120 mg
n=1 participants at risk
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 240 mg by mouth (PO) twice a day (BID) foll/by Cycle=28 days,Pazopanib: 600 mg by mouth (PO) every day (QD),ARQ 197: 120 mg by mouth (PO) twice a day (BID)
|
Dose Level 5: Pazopanib: 800 mg & ARQ 197: 360 mg
n=16 participants at risk
Cycle=28 days,Pazopanib: 800 mg by mouth (PO) every day (QD),ARQ 197: 360 mg by mouth (PO) twice a day (BID)
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
4/16 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
4/16 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
37.5%
6/16 • Number of events 10 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Immune system disorders
Allergic reaction
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
43.8%
7/16 • Number of events 11 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
37.5%
6/16 • Number of events 8 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
General disorders
Fever
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
37.5%
6/16 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Musculoskeletal and connective tissue disorders
Cardiac disorders - Other, non cardiac chest pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
General disorders
Chills
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
4/16 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
37.5%
6/16 • Number of events 10 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
General disorders
Edema face
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Eye disorders
Eye disorders - Other, diplopia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Eye disorders
Eye disorders - Other, eye irritation
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Eye disorders
Floaters
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
43.8%
7/16 • Number of events 7 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Vascular disorders
Hypertension
|
100.0%
3/3 • Number of events 85 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
3/3 • Number of events 45 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
2/2 • Number of events 56 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 11 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
75.0%
3/4 • Number of events 87 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 49 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
81.2%
13/16 • Number of events 188 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
75.0%
12/16 • Number of events 28 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
43.8%
7/16 • Number of events 8 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
31.2%
5/16 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Infections and infestations
Lip infection
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Number of events 16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
75.0%
3/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 8 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
56.2%
9/16 • Number of events 22 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
31.2%
5/16 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 8 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
43.8%
7/16 • Number of events 12 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Ear and labyrinth disorders
Otitis externa
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
4/16 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Dysuria
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, chest congestion
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Cardiac disorders
Sinus bradycardia
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
4/4 • Number of events 11 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
68.8%
11/16 • Number of events 18 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Graying of hair
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, hair hypopigmentation
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, skin/hair graying
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, whitening of hair
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, hypo pigmented of facial hair
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Stomach pain
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
100.0%
3/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
18.8%
3/16 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
25.0%
4/16 • Number of events 7 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Weight gain
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/16 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Number of events 12 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
100.0%
1/1 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
50.0%
8/16 • Number of events 21 • Date treatment consent signed to date off study, approximately 22 mos./2 days; 13 mos./20 days; 5 mos./23 days; 17 mos./24 days; 7 mos./5 days; 5 mos./5 days; 5 mos./13 days; and 23 mos./21 days for Dose Level (DL) 1, DL2, DL3, DL3 followed by DL2, DL4, DL4 followed by DL3, DL 4 followed by DL 3 followed by DL2; and DL5 respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place