Trial Outcomes & Findings for TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas (NCT NCT01851369)
NCT ID: NCT01851369
Last Updated: 2024-05-08
Results Overview
Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on-study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Response rate at one year
Results posted on
2024-05-08
Participant Flow
Participant milestones
| Measure |
Phase (Ph) 1 Dose Level -2 Methoxyamine (TRC102) 25mg & Temozolomide (TMZ) 75mg/m^2
No participants were enrolled in this group. Cycle = 28 days; Methoxyamine (TRC102) 25mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 75mg/m\^2 PO QD on days 1-5.
|
Phase 1 Dose Level -1 Methoxyamine (TRC102) 25mg & Temozolomide 100mg/m^2
No participants were enrolled in this group. Cycle = 28 days; Methoxyamine (TRC102) 25mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 100mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 1 Methoxyamine (TRC102) 125mg & Temozolomide 75mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 75mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 2 Methoxyamine (TRC102) 50mg & Temozolomide 125mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 50mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 125mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 3 Methoxyamine (TRC102) 50mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 50mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I Dose Escalation
STARTED
|
0
|
0
|
3
|
6
|
4
|
8
|
3
|
3
|
5
|
3
|
0
|
0
|
0
|
|
Phase I Dose Escalation
COMPLETED
|
0
|
0
|
3
|
6
|
4
|
7
|
3
|
3
|
5
|
3
|
0
|
0
|
0
|
|
Phase I Dose Escalation
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I Maximum Tolerated Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
10
|
0
|
0
|
0
|
0
|
|
Phase I Maximum Tolerated Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
10
|
0
|
0
|
0
|
0
|
|
Phase I Maximum Tolerated Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase II
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
16
|
9
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
16
|
9
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase (Ph) 1 Dose Level -2 Methoxyamine (TRC102) 25mg & Temozolomide (TMZ) 75mg/m^2
No participants were enrolled in this group. Cycle = 28 days; Methoxyamine (TRC102) 25mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 75mg/m\^2 PO QD on days 1-5.
|
Phase 1 Dose Level -1 Methoxyamine (TRC102) 25mg & Temozolomide 100mg/m^2
No participants were enrolled in this group. Cycle = 28 days; Methoxyamine (TRC102) 25mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 100mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 1 Methoxyamine (TRC102) 125mg & Temozolomide 75mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 75mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 2 Methoxyamine (TRC102) 50mg & Temozolomide 125mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 50mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 125mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 3 Methoxyamine (TRC102) 50mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 50mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase I Dose Escalation
Declined to participate (before treatment started)
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas
Baseline characteristics by cohort
| Measure |
Phase 1 Solid Tumor Dose Level 1 Methoxyamine (TRC102) 125mg & Temozolomide 75mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 75mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 2 Methoxyamine (TRC102) 50mg & Temozolomide 125mg/m^2
n=6 Participants
Cycle = 28 days; Methoxyamine (TRC102) 50mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 125mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 3 Methoxyamine (TRC102) 50mg & Temozolomide 150mg/m^2
n=4 Participants
Cycle = 28 days; Methoxyamine (TRC102) 50mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
n=8 Participants
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
n=10 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
n=15 Participants
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=16 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
n=16 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
n=9 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
63 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
|
Age, Continuous
|
59.13 years
STANDARD_DEVIATION 12.22 • n=5 Participants
|
57.82 years
STANDARD_DEVIATION 6.83 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 14.03 • n=5 Participants
|
58.54 years
STANDARD_DEVIATION 5.37 • n=4 Participants
|
48.57 years
STANDARD_DEVIATION 11.52 • n=21 Participants
|
58.44 years
STANDARD_DEVIATION 10.45 • n=10 Participants
|
61.51 years
STANDARD_DEVIATION 11.25 • n=115 Participants
|
57 years
STANDARD_DEVIATION 5.91 • n=24 Participants
|
62.24 years
STANDARD_DEVIATION 10.75 • n=42 Participants
|
61.97 years
STANDARD_DEVIATION 14.1 • n=42 Participants
|
49.14 years
STANDARD_DEVIATION 18.4 • n=42 Participants
|
59.11 years
STANDARD_DEVIATION 12.13 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
43 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
50 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
84 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
7 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
68 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
8 participants
n=4 Participants
|
3 participants
n=21 Participants
|
10 participants
n=10 Participants
|
15 participants
n=115 Participants
|
3 participants
n=24 Participants
|
16 participants
n=42 Participants
|
16 participants
n=42 Participants
|
9 participants
n=42 Participants
|
93 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Response rate at one yearPopulation: A total of 41/93 participants were analyzed: 0/52 phase 1 participants were analyzed as this outcome measure was for the phase 2 participants only; 41/41 phase 2 participants were evaluable for response rate.
Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on-study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=16 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
n=16 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
n=9 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Response Rate of This Combination in Participants With Colon Cancer, Non-small Cell Lung Cancer (NSCLC), and Granulosa Cell Ovarian Cancer
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Response Rate of This Combination in Participants With Colon Cancer, Non-small Cell Lung Cancer (NSCLC), and Granulosa Cell Ovarian Cancer
Partial Response
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Response Rate of This Combination in Participants With Colon Cancer, Non-small Cell Lung Cancer (NSCLC), and Granulosa Cell Ovarian Cancer
Stable Disease
|
3 Participants
|
10 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Response Rate of This Combination in Participants With Colon Cancer, Non-small Cell Lung Cancer (NSCLC), and Granulosa Cell Ovarian Cancer
Progressive Disease
|
8 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Response Rate of This Combination in Participants With Colon Cancer, Non-small Cell Lung Cancer (NSCLC), and Granulosa Cell Ovarian Cancer
Not Assessed Due to Death on Study
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Response Rate of This Combination in Participants With Colon Cancer, Non-small Cell Lung Cancer (NSCLC), and Granulosa Cell Ovarian Cancer
Not Assessed Due to Clinical Progression
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Response Rate of This Combination in Participants With Colon Cancer, Non-small Cell Lung Cancer (NSCLC), and Granulosa Cell Ovarian Cancer
Not Assessed Due to Refusing Further Treatment
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At dose-limiting toxicity (DLT) determined in the first cycle; approximately 28 daysPopulation: 36/37 participants in the phase I dose escalation cohort were analyzed because one participant in dose level 3 declined to participate (before treatment started).
Dose-limiting toxicities (DLTs) are defined as toxicities occurring within the first cycle of treatment felt to be possibly, probably, or definitely related to administration of study drugs and fulfilling one of the following criteria: Grade 4 neutropenia, febrile neutropenia, neutropenic infection: Grade ≥ 3 neutropenia with grade ≥ 3 infection, Grade ≥ 3 thrombocytopenia, a drop in hemoglobin (Hgb) ≥3.0 g/dL over one week, and all Grade ≥ 3 non-hematologic toxicity other than: non-bloody diarrhea Grade 3 that is corrected to Grade ≤ 2 within 24 hours, nausea and vomiting Grade 3 that is corrected to Grade ≤ 1 within 24 hours, creatinine Grade 3 corrected to Grade ≤ 1 within 48 hours, and Grade 3 electrolyte abnormalities. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. And Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
n=6 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
n=4 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
n=7 Participants
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
n=7 Participants
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Dose Limiting Toxicities Observed in Participants Receiving Oral TRC102 in Combination With Oral TMZ
A Drop in Hemoglobin (Hgb) ≥3.0 g/dL Over One Week
|
0 Dose limiting toxicities
|
1 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
2 Dose limiting toxicities
|
—
|
—
|
—
|
|
The Number of Dose Limiting Toxicities Observed in Participants Receiving Oral TRC102 in Combination With Oral TMZ
Grade 4 Neutropenia
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
1 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
1 Dose limiting toxicities
|
—
|
—
|
—
|
|
The Number of Dose Limiting Toxicities Observed in Participants Receiving Oral TRC102 in Combination With Oral TMZ
Grade 4 Thrombocytopenia
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
1 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
0 Dose limiting toxicities
|
1 Dose limiting toxicities
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First 5 days of treatmentPopulation: 51/52 participants were analyzed for plasma PK in phase 1 because one participant declined to participate (before treatment started).
Blood samples will be collected, and pharmacokinetics will be assessed in the phase I portion of the study. Samples will be analyzed using a validated LC-MS or LC-MS/MS method in human plasma. The maximum observed analyte concentration in plasma was reported.
Outcome measures
| Measure |
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
n=6 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
n=4 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
n=7 Participants
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
n=10 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
n=15 Participants
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Pharmacokinetic (PK) Profile of Oral TRC102 When Administered in Combination With Temozolomide (TMZ) as Measured by Maximum Plasma Concentration (Cmax) of TRC102: Mean (Standard Deviation)
|
0.75 Micromolar (µM)
Standard Deviation 0.49
|
1.49 Micromolar (µM)
Standard Deviation 1.07
|
0.97 Micromolar (µM)
Standard Deviation 0.27
|
2.36 Micromolar (µM)
Standard Deviation 2.68
|
3.51 Micromolar (µM)
Standard Deviation 2.52
|
7.11 Micromolar (µM)
Standard Deviation 8.21
|
7.45 Micromolar (µM)
Standard Deviation 5.39
|
7.54 Micromolar (µM)
Standard Deviation 5.40
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First day of treatmentPopulation: 51/52 participants were analyzed for urine PK in phase 1 because one participant declined to participate (before treatment started).
Urine samples will be collected, and pharmacokinetics will be assessed in phase I portion of the study. Samples will be analyzed using a validated liquid chromatography-mass spectrometry (LC-MS) or liquid chromatography with tandem mass spectrometry (LC-MS-MS) method.
Outcome measures
| Measure |
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
n=6 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
n=4 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
n=7 Participants
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
n=10 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
n=15 Participants
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Pharmacokinetic (PK) Profile: the Percentage of TRC102 Dose Recovered From Participant Urine in Participants Treated With Oral TRC102 in Combination With Temozolomide (TMZ)
|
1.6 Percentage
Standard Deviation 1.2
|
0.8 Percentage
Standard Deviation 0.3
|
0.8 Percentage
Standard Deviation 0.5
|
2.5 Percentage
Standard Deviation 2.9
|
4.0 Percentage
Standard Deviation 3.1
|
4.8 Percentage
Standard Deviation 5.2
|
4.1 Percentage
Standard Deviation 4.6
|
3.8 Percentage
Standard Deviation 2.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First cycle of treatment; approximately 28 daysPopulation: 51/52 participants were analyzed in phase 1 because one participant declined to participate (before treatment started).
The MTD or recommended Phase II dose is the dose level at which no more than 1 of 6 participants experience dose-limiting toxicity (DLT) during the first cycle of treatment, and the dose below that at which at least 2 (of ≤ 6) participants have DLT as a result of the drug. DLTs are defined as toxicities occurring within the first cycle of treatment felt to be possibly, probably, or definitely related to administration of study drugs and fulfilling one of the following criteria: Grade 4 neutropenia, febrile neutropenia, neutropenic infection: Grade ≥ 3 neutropenia with grade ≥ 3 infection, Grade ≥ 3 thrombocytopenia, a drop in hemoglobin (Hgb) ≥3.0 g/dL over one week, and all Grade ≥ 3 non-hematologic toxicities other than: non-bloody diarrhea Grade 3 that is corrected to Grade ≤ 2 within 24 hours, nausea and vomiting Grade 3 that is corrected to Grade ≤ 1 within 24 hours, creatinine Grade 3 corrected to Grade ≤ 1 within 48 hours, and Grade 3 electrolyte abnormalities.
Outcome measures
| Measure |
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=51 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Maximum Tolerated Dose (MTD) of Oral TRC102 in Participants With Refractory Solid Tumors.
|
125 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First cycle of treatment; approximately 28 daysPopulation: 51/52 participants were analyzed in phase 1 because one participant declined to participate (before treatment started).
The MTD or recommended Phase II dose is the dose level at which no more than 1 of 6 participants experience dose-limiting toxicity (DLT) during the first cycle of treatment, and the dose below that at which at least 2 (of ≤ 6) participants have DLT as a result of the drug. DLTs will be defined as toxicities occurring within the first cycle of treatment and is felt to be possibly, probably, or definitely related to administration of study drugs and fulfills one of the following criteria: hematologic toxicities - Grade 4 neutropenia, febrile neutropenia, neutropenic infection: Grade ≥ 3 neutropenia with grade ≥ 3 infection, Grade ≥ 3 thrombocytopenia, a drop in hemoglobin (Hgb) ≥3.0 g/dL over one week, any degree of lymphopenia, or leukopenia in the absence of grade 4 neutropenia will not be considered dose limiting, and Grade ≥ 3 non-hematologic toxicity. Grade ≥ 3 electrolyte abnormalities will not be considered dose limiting.
Outcome measures
| Measure |
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=51 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Maximum Tolerated Dose (MTD) of Oral Temozolomide (TMZ) in Participants With Refractory Solid Tumors.
|
150 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Duration on study, an average of 130 daysPopulation: 41/41 participants in phase 2 were analyzed. 0/52 participants in phase 1 were analyzed as this was a Phase 2-specific outcome measure, thus the table reports data for phase 2 reporting groups only.
Progression free survival rate of this combination in participants with colon cancer, NSCLC, and granulosa cell ovarian cancer. Progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum onstudy (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
Outcome measures
| Measure |
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=16 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
n=16 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
n=9 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Progression Free Survival Rate of This Combination in Participants With Colon Cancer, Non-small Cell Lung Cancer (NSCLC), and Granulosa Cell Ovarian Cancer
|
1.97 Months
Interval 0.6 to 6.2
|
3.02 Months
Interval 1.2 to 15.1
|
5.52 Months
Interval 0.9 to 25.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, an average of 115 days.Population: 92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
n=6 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
n=4 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
n=7 Participants
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
n=10 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
n=15 Participants
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
n=3 Participants
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=16 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
n=16 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
n=9 Participants
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
3.0 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
10 Participants
|
15 Participants
|
3 Participants
|
16 Participants
|
16 Participants
|
9 Participants
|
Adverse Events
Phase 1 Solid Tumor Dose Level 1 Methoxyamine (TRC102) 125mg & Temozolomide 75mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Solid Tumor Dose Level 2 Methoxyamine (TRC102) 50mg & Temozolomide 125mg/m^2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1 Solid Tumor Dose Level 3 Methoxyamine (TRC102) 50mg & Temozolomide 150mg/m^2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
Serious events: 4 serious events
Other events: 10 other events
Deaths: 2 deaths
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
Serious events: 9 serious events
Other events: 15 other events
Deaths: 2 deaths
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
Serious events: 9 serious events
Other events: 16 other events
Deaths: 1 deaths
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
Serious events: 9 serious events
Other events: 16 other events
Deaths: 0 deaths
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1 Solid Tumor Dose Level 1 Methoxyamine (TRC102) 125mg & Temozolomide 75mg/m^2
n=3 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 75mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 2 Methoxyamine (TRC102) 50mg & Temozolomide 125mg/m^2
n=6 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 50mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 125mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 3 Methoxyamine (TRC102) 50mg & Temozolomide 150mg/m^2
n=4 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 50mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
n=7 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
n=3 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
n=10 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
n=15 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
n=3 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=16 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
n=16 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
n=9 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Pneuomonitis
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Chills
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
31.2%
5/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Fatigue
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Fever
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Infections and infestations - Other, covid-19
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
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, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Sudden death NOS
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Weight loss
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
Other adverse events
| Measure |
Phase 1 Solid Tumor Dose Level 1 Methoxyamine (TRC102) 125mg & Temozolomide 75mg/m^2
n=3 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 75mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 2 Methoxyamine (TRC102) 50mg & Temozolomide 125mg/m^2
n=6 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 50mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 125mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 3 Methoxyamine (TRC102) 50mg & Temozolomide 150mg/m^2
n=4 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 50mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 4 Methoxyamine (TRC102) 75mg & Temozolomide 150mg/m^2
n=7 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 75mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 5 Methoxyamine (TRC102) 100mg & Temozolomide 150mg/m^2
n=3 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 6 Methoxyamine (TRC102) 125mg & Temozolomide 150mg/m^2
n=10 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 7 Methoxyamine (TRC102) 150mg & Temozolomide 150mg/m^2
n=15 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5.
|
Phase 1 Solid Tumor Dose Level 8 Methoxyamine (TRC102) 150mg & Temozolomide 200mg/m^2
n=3 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 150mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 200mg/m\^2 PO QD on days 1-5.
|
Ph 2 Colorectal Cancer TMZ 150mg/m^2/Methoxyamine 125mgOR100mg(Based on Body Surface Area)
n=16 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph2 Non Small Cell Lung Cancer TMZ 150mg/m^2/Methoxyamine125mgOR100mg(Based on Body Surface Area)
n=16 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
Ph 2 Granulosa Cell Temozolomide 150mg/m^2 & Methoxyamine 125mgOR 100mg (Based on Body Surface Area)
n=9 participants at risk
Cycle = 28 days; Methoxyamine (TRC102) 125mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) ≥ 1.6 m\^2 OR Cycle = 28 days; Methoxyamine (TRC102) 100mg by mouth (PO) everyday (QD) on days 1-5; Temozolomide (TMZ) 150mg/m\^2 PO QD on days 1-5 for participants with a body surface area (BSA) \< 1.6 m\^2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
3/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
3/9 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
2/4 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
30.0%
3/10 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
5/15 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
31.2%
5/16 • Number of events 10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
43.8%
7/16 • Number of events 14 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
44.4%
4/9 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
3/15 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
31.2%
5/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
INR increased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
26.7%
4/15 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
26.7%
4/15 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
31.2%
5/16 • Number of events 8 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
30.0%
3/10 • Number of events 8 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
40.0%
6/15 • Number of events 8 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
57.1%
4/7 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
46.7%
7/15 • Number of events 10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
3/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
3/6 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
100.0%
4/4 • Number of events 10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
57.1%
4/7 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
80.0%
8/10 • Number of events 18 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
10/15 • Number of events 20 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
100.0%
3/3 • Number of events 19 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
75.0%
12/16 • Number of events 16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
8/16 • Number of events 16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
6/9 • Number of events 12 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
60.0%
6/10 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
5/15 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
37.5%
6/16 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
3/6 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
5/10 • Number of events 9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
5/15 • Number of events 10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
30.0%
3/10 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
10/15 • Number of events 14 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
31.2%
5/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
31.2%
5/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
3/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
CPK increased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Chills
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
28.6%
2/7 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
30.0%
3/10 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
26.7%
4/15 • Number of events 9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
31.2%
5/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
31.2%
5/16 • Number of events 9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
3/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
31.2%
5/16 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
2/4 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
42.9%
3/7 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
3/15 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
3/9 • Number of events 8 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
4/6 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
55.6%
5/9 • Number of events 11 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
5/15 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
3/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Edema face
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
40.0%
6/15 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Eye disorders
Eye disorders - Other, right scleral irritation
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
75.0%
3/4 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
40.0%
4/10 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
37.5%
6/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
56.2%
9/16 • Number of events 16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
44.4%
4/9 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Fever
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
42.9%
3/7 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Flashing lights
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Flu like symptoms
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, hypersalivation
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
General disorders and administration site conditions - Other, night sweat
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
26.7%
4/15 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
2/6 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
3/15 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
3/9 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Hoarseness
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
3/15 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
43.8%
7/16 • Number of events 15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
55.6%
5/9 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
26.7%
4/15 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 12 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
100.0%
6/6 • Number of events 15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
26.7%
4/15 • Number of events 8 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
8/16 • Number of events 14 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
44.4%
4/9 • Number of events 8 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
2/4 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
5/10 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
10/15 • Number of events 15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
62.5%
10/16 • Number of events 14 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
43.8%
7/16 • Number of events 9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Investigations - Other, LDH increased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Localized edema
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
75.0%
3/4 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
42.9%
3/7 • Number of events 8 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
60.0%
6/10 • Number of events 14 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
10/15 • Number of events 19 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
100.0%
3/3 • Number of events 15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
62.5%
10/16 • Number of events 19 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
68.8%
11/16 • Number of events 24 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 11 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Malaise
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, cramping
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
100.0%
6/6 • Number of events 8 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
75.0%
3/4 • Number of events 9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
85.7%
6/7 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
5/10 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
10/15 • Number of events 27 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
100.0%
3/3 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
43.8%
7/16 • Number of events 9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
68.8%
11/16 • Number of events 22 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
88.9%
8/9 • Number of events 14 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 8 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Ear and labyrinth disorders
Otitis externa
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
General disorders
Pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
3/15 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
3/15 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
57.1%
4/7 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
40.0%
6/15 • Number of events 9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
100.0%
3/3 • Number of events 10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
31.2%
5/16 • Number of events 17 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
2/6 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Chest congestion
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
3/15 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Thrush
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
13.3%
2/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
22.2%
2/9 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Urinary urgency
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.7%
1/15 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
3/3 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
4/6 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
57.1%
4/7 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
30.0%
3/10 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
46.7%
7/15 • Number of events 11 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
18.8%
3/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
43.8%
7/16 • Number of events 15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
55.6%
5/9 • Number of events 5 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Weight gain
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
Weight loss
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
20.0%
3/15 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
25.0%
4/16 • Number of events 8 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/10 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/15 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
6.2%
1/16 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 4 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/9 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
50.0%
2/4 • Number of events 12 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/3 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
26.7%
4/15 • Number of events 11 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
100.0%
3/3 • Number of events 7 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
0.00%
0/16 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
12.5%
2/16 • Number of events 6 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
11.1%
1/9 • Number of events 1 • Date treatment consent signed to date off study, an average of 115 days.
92/93 participants were analyzed because one participant in phase 1 dose level 3 declined to participate (before treatment started).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place