Trial Outcomes & Findings for A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors. (NCT NCT04209465)
NCT ID: NCT04209465
Last Updated: 2025-04-17
Results Overview
Certain toxicities will be considered dose-limiting unless clearly attributable to an extraneous cause, such as underlying disease.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
91 participants
Primary outcome timeframe
After the first dose of treatment for up to 21 days.
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
Dose Escalation 25 mg QD
Patients who received doses at 25 mg once daily under fasted conditions.
|
Dose Escalation 50 mg QD
Patients who received doses at 50 mg once daily under fasted conditions.
|
Dose Escalation 100 mg QD
Patients who received doses at 100 mg once daily under fasted conditions.
|
Dose Escalation 200 mg QD
Patients who received doses at 200 mg once daily under fasted conditions.
|
Dose Escalation 400 mg QD
Patients who received 400 mg once daily under fasted conditions.
|
Dose Escalation 800 mg QD
Patients who received 800 mg once daily under fasted conditions.
|
Dose Escalation 800 mg QD Not Fasted
Patients who received 800 mg once daily under not fasted conditions.
|
Dose Escalation 1000 mg QD
Patients who received 1000 mg once daily under fasted condition.
|
Dose Escalation 1200 mg QD
Patients who received 1200 mg once daily under fasted conditions.
|
Dose Escalation 400 mg BID
Patients who received 400 mg twice daily under not fasted conditions.
|
Dose Escalation 600 mg BID
Patients who received 600 mg twice daily under not fasted conditions.
|
Dose Escalation 800 mg BID
Patients who received 800 mg twice daily under fasted conditions.
|
Phase 1 Safety Expansion
Patients who received 800 mg once daily as a safety expansion group under not fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
2
|
10
|
18
|
13
|
7
|
6
|
4
|
6
|
5
|
17
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
1
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
2
|
10
|
16
|
10
|
6
|
6
|
4
|
5
|
5
|
16
|
Reasons for withdrawal
| Measure |
Dose Escalation 25 mg QD
Patients who received doses at 25 mg once daily under fasted conditions.
|
Dose Escalation 50 mg QD
Patients who received doses at 50 mg once daily under fasted conditions.
|
Dose Escalation 100 mg QD
Patients who received doses at 100 mg once daily under fasted conditions.
|
Dose Escalation 200 mg QD
Patients who received doses at 200 mg once daily under fasted conditions.
|
Dose Escalation 400 mg QD
Patients who received 400 mg once daily under fasted conditions.
|
Dose Escalation 800 mg QD
Patients who received 800 mg once daily under fasted conditions.
|
Dose Escalation 800 mg QD Not Fasted
Patients who received 800 mg once daily under not fasted conditions.
|
Dose Escalation 1000 mg QD
Patients who received 1000 mg once daily under fasted condition.
|
Dose Escalation 1200 mg QD
Patients who received 1200 mg once daily under fasted conditions.
|
Dose Escalation 400 mg BID
Patients who received 400 mg twice daily under not fasted conditions.
|
Dose Escalation 600 mg BID
Patients who received 600 mg twice daily under not fasted conditions.
|
Dose Escalation 800 mg BID
Patients who received 800 mg twice daily under fasted conditions.
|
Phase 1 Safety Expansion
Patients who received 800 mg once daily as a safety expansion group under not fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
2
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
2
|
7
|
2
|
2
|
1
|
1
|
1
|
0
|
10
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
0
|
0
|
1
|
2
|
8
|
5
|
3
|
4
|
1
|
3
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Started new therapy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study terminated early by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
Baseline characteristics by cohort
| Measure |
Dose Escalation 25 mg QD
n=1 Participants
Patients who received doses at 25 mg once daily under fasted conditions.
|
Dose Escalation 50 mg QD
n=1 Participants
Patients who received doses at 50 mg once daily under fasted conditions.
|
Dose Escalation 100 mg QD
n=1 Participants
Patients who received doses at 100 mg once daily under fasted conditions.
|
Dose Escalation 200 mg QD
n=2 Participants
Patients who received doses at 200 mg once daily under fasted conditions.
|
Dose Escalation 400 mg QD
n=10 Participants
Patients who received 400 mg once daily under fasted conditions.
|
Dose Escalation 800 mg QD
n=18 Participants
Patients who received 800 mg once daily under fasted conditions.
|
Dose Escalation 800 mg QD NF
n=13 Participants
Patients who received 800 mg once daily under not fasted conditions.
|
Dose Escalation 1000 mg QD
n=7 Participants
Patients who received 1000 mg once daily under not fasted conditions
|
Dose Escalation 1200 mg QD
n=6 Participants
Patients who received 1200 mg once daily under fasted conditions.
|
Dose Escalation 400 mg BID
n=4 Participants
Patients who received 400 mg twice daily under not fasted conditions.
|
Dose Escalation 600 mg BID
n=6 Participants
Patients who received 600 mg twice daily under not fasted conditions.
|
Dose Escalation 800 mg BID
n=5 Participants
Patients who received 800 mg twice daily under fasted conditions.
|
Safety Expansion 800 mg QD
n=17 Participants
Patients in safety expansion who received 800 mg once daily under not fasted conditions.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
0 Participants
|
4 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=7 Participants
|
52 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
4 Participants
|
2 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=7 Participants
|
39 Participants
n=7 Participants
|
|
Age, Continuous
|
56 years
n=99 Participants
|
65 years
n=107 Participants
|
51 years
n=206 Participants
|
60 years
STANDARD_DEVIATION 17.0 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 9.48 • n=31 Participants
|
65.4 years
STANDARD_DEVIATION 11.94 • n=30 Participants
|
60.2 years
STANDARD_DEVIATION 7.00 • n=3 Participants
|
61.4 years
STANDARD_DEVIATION 7.00 • n=6 Participants
|
55.8 years
STANDARD_DEVIATION 6.59 • n=114 Participants
|
71.0 years
STANDARD_DEVIATION 6.06
|
59.3 years
STANDARD_DEVIATION 11.99 • n=19 Participants
|
58.0 years
STANDARD_DEVIATION 5.70 • n=4 Participants
|
65.3 years
STANDARD_DEVIATION 10.34 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 10.26 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
3 Participants
|
5 Participants
n=19 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=7 Participants
|
54 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=7 Participants
|
37 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
4 Participants
|
4 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=7 Participants
|
74 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
10 participants
n=31 Participants
|
18 participants
n=30 Participants
|
13 participants
n=3 Participants
|
7 participants
n=6 Participants
|
6 participants
n=114 Participants
|
4 participants
|
6 participants
n=19 Participants
|
5 participants
n=4 Participants
|
12 participants
n=7 Participants
|
86 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
0 participants
n=114 Participants
|
0 participants
|
0 participants
n=19 Participants
|
0 participants
n=4 Participants
|
5 participants
n=7 Participants
|
5 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: After the first dose of treatment for up to 21 days.Population: DLT-Evaluable
Certain toxicities will be considered dose-limiting unless clearly attributable to an extraneous cause, such as underlying disease.
Outcome measures
| Measure |
25 mg QD
n=1 Participants
Patients who received doses at 25 mg once daily under fasted conditions.
|
50 mg QD
n=1 Participants
Patients who received doses at 50 mg once daily under fasted conditions.
|
100 mg QD
n=1 Participants
Patients who received doses at 100 mg once daily under fasted conditions.
|
200 mg QD
n=2 Participants
Patients who received doses at 200 mg once daily under fasted conditions.
|
400 mg QD
n=10 Participants
Patients dosed at 400 mg once daily under fasted conditions
|
800 mg QD Fasted
n=18 Participants
Patients enrolled at 800 mg once daily under fasted conditions
|
800 mg QD Not Fasted
n=13 Participants
Patients enrolled at 800 mg once daily under not fasted conditions
|
1000 mg QD
n=7 Participants
Patients enrolled at 1000 mg once daily under not fasted conditions
|
1200 mg QD
n=6 Participants
Patients enrolled at 1200 mg once daily under fasted conditions
|
400 mg BID
n=4 Participants
Patients enrolled at 400 mg twice daily under not fasted conditions
|
600 mg BID
n=6 Participants
Patients enrolled at 600 mg twice daily under not fasted conditions
|
800 mg BID
n=5 Participants
Patients enrolled at 800 mg twice daily under fasted conditions
|
Safety Expansion Set 800 mg QD
n=17 Participants
Safety expansion group patients enrolled at 800 mg once daily under not fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Dose Limiting Toxicities as a Determinant of the Recommended Phase 2 Dose (RP2D)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
3 participants
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 (each cycle is 21 days) until 30 days post last doseAdverse events will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Outcome measures
| Measure |
25 mg QD
n=1 Participants
Patients who received doses at 25 mg once daily under fasted conditions.
|
50 mg QD
n=1 Participants
Patients who received doses at 50 mg once daily under fasted conditions.
|
100 mg QD
n=1 Participants
Patients who received doses at 100 mg once daily under fasted conditions.
|
200 mg QD
n=2 Participants
Patients who received doses at 200 mg once daily under fasted conditions.
|
400 mg QD
n=10 Participants
Patients dosed at 400 mg once daily under fasted conditions
|
800 mg QD Fasted
n=18 Participants
Patients enrolled at 800 mg once daily under fasted conditions
|
800 mg QD Not Fasted
n=13 Participants
Patients enrolled at 800 mg once daily under not fasted conditions
|
1000 mg QD
n=7 Participants
Patients enrolled at 1000 mg once daily under not fasted conditions
|
1200 mg QD
n=6 Participants
Patients enrolled at 1200 mg once daily under fasted conditions
|
400 mg BID
n=4 Participants
Patients enrolled at 400 mg twice daily under not fasted conditions
|
600 mg BID
n=6 Participants
Patients enrolled at 600 mg twice daily under not fasted conditions
|
800 mg BID
n=5 Participants
Patients enrolled at 800 mg twice daily under fasted conditions
|
Safety Expansion Set 800 mg QD
n=17 Participants
Safety expansion group patients enrolled at 800 mg once daily under not fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Incidence of Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of BDTX-189
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
10 Participants
|
18 Participants
|
13 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Multiple time points during Cycles 1-4 (each cycle is 21 days)Blood samples will be taken to measure the plasma concentrations of BDTX-189 in both a fed and fasted state.
Outcome measures
| Measure |
25 mg QD
n=1 Participants
Patients who received doses at 25 mg once daily under fasted conditions.
|
50 mg QD
n=1 Participants
Patients who received doses at 50 mg once daily under fasted conditions.
|
100 mg QD
n=1 Participants
Patients who received doses at 100 mg once daily under fasted conditions.
|
200 mg QD
n=2 Participants
Patients who received doses at 200 mg once daily under fasted conditions.
|
400 mg QD
n=9 Participants
Patients dosed at 400 mg once daily under fasted conditions
|
800 mg QD Fasted
n=13 Participants
Patients enrolled at 800 mg once daily under fasted conditions
|
800 mg QD Not Fasted
n=11 Participants
Patients enrolled at 800 mg once daily under not fasted conditions
|
1000 mg QD
n=1 Participants
Patients enrolled at 1000 mg once daily under not fasted conditions
|
1200 mg QD
n=3 Participants
Patients enrolled at 1200 mg once daily under fasted conditions
|
400 mg BID
n=3 Participants
Patients enrolled at 400 mg twice daily under not fasted conditions
|
600 mg BID
n=2 Participants
Patients enrolled at 600 mg twice daily under not fasted conditions
|
800 mg BID
n=3 Participants
Patients enrolled at 800 mg twice daily under fasted conditions
|
Safety Expansion Set 800 mg QD
n=22 Participants
Safety expansion group patients enrolled at 800 mg once daily under not fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Plasma Concentration of BDTX-189 as a Measure of Pharmacokinetics
|
NA Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean (Geometric Coefficient of Variation) is not calculable for a single participant.
|
NA Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean (Geometric Coefficient of Variation) is not calculable for a single participant.
|
NA Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean (Geometric Coefficient of Variation) is not calculable for a single participant.
|
151 Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 67.5
|
170 Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 104
|
268 Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 72.7
|
341 Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 46.4
|
0 Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 0
|
352 Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 77.8
|
123 Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 133
|
84.5 Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 39
|
165 Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 53.8
|
248 Nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 77.8
|
SECONDARY outcome
Timeframe: Assessed until disease progression or death for up to 12 monthsObjective response is defined as the proportion of participants who achieved a complete response (CR; disappearance of all target and non-target lesions) or partial response (PR; at least a 30% decrease from baseline in the sum of diameters of target lesions) per RECIST version 1.1.
Outcome measures
| Measure |
25 mg QD
n=1 Participants
Patients who received doses at 25 mg once daily under fasted conditions.
|
50 mg QD
n=1 Participants
Patients who received doses at 50 mg once daily under fasted conditions.
|
100 mg QD
n=1 Participants
Patients who received doses at 100 mg once daily under fasted conditions.
|
200 mg QD
n=2 Participants
Patients who received doses at 200 mg once daily under fasted conditions.
|
400 mg QD
n=10 Participants
Patients dosed at 400 mg once daily under fasted conditions
|
800 mg QD Fasted
n=18 Participants
Patients enrolled at 800 mg once daily under fasted conditions
|
800 mg QD Not Fasted
n=13 Participants
Patients enrolled at 800 mg once daily under not fasted conditions
|
1000 mg QD
n=7 Participants
Patients enrolled at 1000 mg once daily under not fasted conditions
|
1200 mg QD
n=6 Participants
Patients enrolled at 1200 mg once daily under fasted conditions
|
400 mg BID
n=4 Participants
Patients enrolled at 400 mg twice daily under not fasted conditions
|
600 mg BID
n=6 Participants
Patients enrolled at 600 mg twice daily under not fasted conditions
|
800 mg BID
n=5 Participants
Patients enrolled at 800 mg twice daily under fasted conditions
|
Safety Expansion Set 800 mg QD
n=17 Participants
Safety expansion group patients enrolled at 800 mg once daily under not fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity
Partial response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity
Stable disease (SD)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
7 Participants
|
|
Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity
Progressive disease (PD)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
|
Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity
Non-complete response/non-partial response (non-CR/non-PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity
Not evaluable (NE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed until disease progression or death for up to 12 monthsProgression-free survival is the time from first study dose until disease progression (PD; target lesion increase of 20% and at least 5mm from smallest on-study lesion sum, the appearance of new lesions, or unequivocal progression of non-target lesions) per RECIST v1.1.
Outcome measures
| Measure |
25 mg QD
n=1 Participants
Patients who received doses at 25 mg once daily under fasted conditions.
|
50 mg QD
n=1 Participants
Patients who received doses at 50 mg once daily under fasted conditions.
|
100 mg QD
n=1 Participants
Patients who received doses at 100 mg once daily under fasted conditions.
|
200 mg QD
n=2 Participants
Patients who received doses at 200 mg once daily under fasted conditions.
|
400 mg QD
n=10 Participants
Patients dosed at 400 mg once daily under fasted conditions
|
800 mg QD Fasted
n=18 Participants
Patients enrolled at 800 mg once daily under fasted conditions
|
800 mg QD Not Fasted
n=13 Participants
Patients enrolled at 800 mg once daily under not fasted conditions
|
1000 mg QD
n=7 Participants
Patients enrolled at 1000 mg once daily under not fasted conditions
|
1200 mg QD
n=6 Participants
Patients enrolled at 1200 mg once daily under fasted conditions
|
400 mg BID
n=4 Participants
Patients enrolled at 400 mg twice daily under not fasted conditions
|
600 mg BID
n=6 Participants
Patients enrolled at 600 mg twice daily under not fasted conditions
|
800 mg BID
n=5 Participants
Patients enrolled at 800 mg twice daily under fasted conditions
|
Safety Expansion Set 800 mg QD
n=17 Participants
Safety expansion group patients enrolled at 800 mg once daily under not fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Progression-free Survival as a Measure of Antitumor Activity
|
0 Months
Interval 0.0 to 0.0
|
0 Months
Interval 0.0 to 0.0
|
0 Months
Interval 0.0 to 0.0
|
1.61 Months
Interval 0.941 to 2.279
|
1.866 Months
Interval 0.909 to 2.115
|
2.306 Months
Interval 0.493 to 4.143
|
5.158 Months
Interval 0.502 to 11.122
|
1.416 Months
Interval 1.147 to 2.189
|
1.572 Months
Interval 0.429 to 2.819
|
1.508 Months
Interval 0.688 to 2.327
|
2.252 Months
Interval 1.434 to 3.482
|
1.354 Months
Interval 0.548 to 2.16
|
1.772 Months
Interval 1.428 to 3.592
|
Adverse Events
Dose Escalation 25 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Escalation 50 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Escalation 100 mg QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Escalation 200 mg QD
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Escalation 400 mg QD
Serious events: 2 serious events
Other events: 10 other events
Deaths: 2 deaths
Dose Escalation 800 mg QD
Serious events: 8 serious events
Other events: 18 other events
Deaths: 7 deaths
Dose Escalation 800 mg QD NF
Serious events: 1 serious events
Other events: 13 other events
Deaths: 2 deaths
Dose Escalation 1000 mg QD
Serious events: 1 serious events
Other events: 7 other events
Deaths: 2 deaths
Dose Escalation 1200 mg QD
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose Escalation 400 mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Escalation 600 mg BID
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose Escalation 800 mg BID
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Safety Expansion 800 mg QD
Serious events: 4 serious events
Other events: 17 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Dose Escalation 25 mg QD
n=1 participants at risk
Patients who received doses at 25 mg once daily under fasted conditions.
|
Dose Escalation 50 mg QD
n=1 participants at risk
Patients who received doses at 50 mg once daily under fasted conditions.
|
Dose Escalation 100 mg QD
n=1 participants at risk
Patients who received doses at 100 mg once daily under fasted conditions.
|
Dose Escalation 200 mg QD
n=2 participants at risk
Patients who received doses at 200 mg once daily under fasted conditions.
|
Dose Escalation 400 mg QD
n=10 participants at risk
Patients who received 400 mg once daily under fasted conditions.
|
Dose Escalation 800 mg QD
n=18 participants at risk
Patients who received 800 mg once daily under fasted conditions.
|
Dose Escalation 800 mg QD NF
n=13 participants at risk
Patients who received 800 mg once daily under not fasted (NF) conditions.
|
Dose Escalation 1000 mg QD
n=7 participants at risk
Patients who received 1000 mg once daily under fasted conditions.
|
Dose Escalation 1200 mg QD
n=6 participants at risk
Patients who received 1200 mg once daily under fasted conditions.
|
Dose Escalation 400 mg BID
n=4 participants at risk
Patients who received 400 mg twice daily under not fasted conditions.
|
Dose Escalation 600 mg BID
n=6 participants at risk
Patients who received 600 mg twice daily under not fasted conditions.
|
Dose Escalation 800 mg BID
n=5 participants at risk
Patients who received 800 mg twice daily under fasted conditions.
|
Safety Expansion 800 mg QD
n=17 participants at risk
Safety expansion group of patients who received 800 mg once daily under not fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Infections and infestations
pneumonia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
1/2 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
1/2 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
General disorders
Death
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Nervous system disorders
Vasogenic cerebral edema
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Large intestinal hemorrhage
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
Other adverse events
| Measure |
Dose Escalation 25 mg QD
n=1 participants at risk
Patients who received doses at 25 mg once daily under fasted conditions.
|
Dose Escalation 50 mg QD
n=1 participants at risk
Patients who received doses at 50 mg once daily under fasted conditions.
|
Dose Escalation 100 mg QD
n=1 participants at risk
Patients who received doses at 100 mg once daily under fasted conditions.
|
Dose Escalation 200 mg QD
n=2 participants at risk
Patients who received doses at 200 mg once daily under fasted conditions.
|
Dose Escalation 400 mg QD
n=10 participants at risk
Patients who received 400 mg once daily under fasted conditions.
|
Dose Escalation 800 mg QD
n=18 participants at risk
Patients who received 800 mg once daily under fasted conditions.
|
Dose Escalation 800 mg QD NF
n=13 participants at risk
Patients who received 800 mg once daily under not fasted (NF) conditions.
|
Dose Escalation 1000 mg QD
n=7 participants at risk
Patients who received 1000 mg once daily under fasted conditions.
|
Dose Escalation 1200 mg QD
n=6 participants at risk
Patients who received 1200 mg once daily under fasted conditions.
|
Dose Escalation 400 mg BID
n=4 participants at risk
Patients who received 400 mg twice daily under not fasted conditions.
|
Dose Escalation 600 mg BID
n=6 participants at risk
Patients who received 600 mg twice daily under not fasted conditions.
|
Dose Escalation 800 mg BID
n=5 participants at risk
Patients who received 800 mg twice daily under fasted conditions.
|
Safety Expansion 800 mg QD
n=17 participants at risk
Safety expansion group of patients who received 800 mg once daily under not fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
1/2 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
30.8%
4/13 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
2/10 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
5/10 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
66.7%
12/18 • Number of events 12 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
69.2%
9/13 • Number of events 9 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
71.4%
5/7 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
66.7%
4/6 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
100.0%
4/4 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
83.3%
5/6 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
100.0%
5/5 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
70.6%
12/17 • Number of events 12 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
40.0%
4/10 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
55.6%
10/18 • Number of events 10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
61.5%
8/13 • Number of events 8 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
57.1%
4/7 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
3/6 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
75.0%
3/4 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
66.7%
4/6 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
60.0%
3/5 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
58.8%
10/17 • Number of events 10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
40.0%
4/10 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
9/18 • Number of events 9 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
30.8%
4/13 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
57.1%
4/7 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
83.3%
5/6 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
2/4 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
3/6 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
60.0%
3/5 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
52.9%
9/17 • Number of events 9 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
22.2%
4/18 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
15.4%
2/13 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
33.3%
2/6 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
2/10 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
15.4%
2/13 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
42.9%
3/7 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
30.0%
3/10 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
33.3%
6/18 • Number of events 6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
38.5%
5/13 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
57.1%
4/7 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
40.0%
2/5 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
41.2%
7/17 • Number of events 7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
2/10 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
38.9%
7/18 • Number of events 7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
38.5%
5/13 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
57.1%
4/7 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
40.0%
2/5 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
41.2%
7/17 • Number of events 7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
71.4%
5/7 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
40.0%
2/5 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
27.8%
5/18 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
28.6%
2/7 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
35.3%
6/17 • Number of events 6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Investigations
Amylase increased
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
15.4%
2/13 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
17.6%
3/17 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Investigations
Lipase increased
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
1/1 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
100.0%
1/1 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
2/10 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
27.8%
5/18 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
28.6%
2/7 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
2/4 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
40.0%
2/5 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
17.6%
3/17 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
33.3%
6/18 • Number of events 6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
33.3%
2/6 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
28.6%
2/7 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
17.6%
3/17 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
General disorders
Fatigue
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
1/2 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
2/10 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
38.9%
7/18 • Number of events 7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
23.1%
3/13 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
57.1%
4/7 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
40.0%
2/5 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
29.4%
5/17 • Number of events 5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
General disorders
Edema peripheral
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
3/18 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
1/2 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
1/1 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
100.0%
1/1 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
3/18 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
15.4%
2/13 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
100.0%
1/1 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
2/10 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
30.8%
4/13 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
15.4%
2/13 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
100.0%
1/1 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
100.0%
1/1 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
33.3%
2/6 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
1/2 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
2/10 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
30.8%
4/13 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
30.0%
3/10 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Infections and infestations
Covid-19
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
15.4%
2/13 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
15.4%
2/13 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
2/10 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.1%
2/18 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
15.4%
2/13 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
2/10 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
15.4%
2/13 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
40.0%
2/5 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Large intestinal hemorrhage
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
General disorders
Localized edema
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
22.2%
4/18 • Number of events 4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Infections and infestations
Wound infection
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
14.3%
1/7 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
25.0%
1/4 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
16.7%
1/6 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
20.0%
1/5 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
11.8%
2/17 • Number of events 2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
17.6%
3/17 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
7.7%
1/13 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
General disorders
Asthenia
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
17.6%
3/17 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
10.0%
1/10 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
17.6%
3/17 • Number of events 3 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.6%
1/18 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
5.9%
1/17 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
50.0%
1/2 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
100.0%
1/1 • Number of events 1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/1 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/2 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/10 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/18 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/13 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/7 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/4 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/6 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/5 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
0.00%
0/17 • Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place