Trial Outcomes & Findings for A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors (NCT NCT03539484)
NCT ID: NCT03539484
Last Updated: 2020-09-03
Results Overview
Number of participants with DLTs.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Up to approximately 12 months
Results posted on
2020-09-03
Participant Flow
Participant milestones
| Measure |
PART1 - RO7172508 - Q3W - 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
PART1 - RO7172508 - Q3W - 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
PART1 - RO7172508 - Q3W - 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
PART2 - RO7172508 - Q3W - 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
PART2 - RO7172508 - Q3W - 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
PART2 - RO7172508 - Q3W - 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
PART2 - RO7172508 - Q3W - 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
3
|
13
|
5
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
3
|
13
|
5
|
2
|
Reasons for withdrawal
| Measure |
PART1 - RO7172508 - Q3W - 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
PART1 - RO7172508 - Q3W - 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
PART1 - RO7172508 - Q3W - 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
PART2 - RO7172508 - Q3W - 400 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
PART2 - RO7172508 - Q3W - 800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
PART2 - RO7172508 - Q3W - 1200 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
PART2 - RO7172508 - Q3W - 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
2
|
8
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
1
|
1
|
2
|
2
|
1
|
Baseline Characteristics
A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
Baseline characteristics by cohort
| Measure |
PART1 - RO7172508 - Q3W - 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
PART1 - RO7172508 - Q3W - 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
PART1 - RO7172508 - Q3W - 400 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
PART2 - RO7172508 - Q3W - 400 mcg
n=3 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
PART2 - RO7172508 - Q3W - 800 mcg
n=13 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
PART2 - RO7172508 - Q3W - 1200 mcg
n=5 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
PART2 - RO7172508 - Q3W - 1800 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.0 Years
STANDARD_DEVIATION NA • n=99 Participants
|
60.0 Years
STANDARD_DEVIATION NA • n=107 Participants
|
60.0 Years
STANDARD_DEVIATION NA • n=206 Participants
|
53.7 Years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
62.2 Years
STANDARD_DEVIATION 9.0 • n=31 Participants
|
58.8 Years
STANDARD_DEVIATION 13.5 • n=30 Participants
|
55.5 Years
STANDARD_DEVIATION 16.3 • n=3 Participants
|
59.5 Years
STANDARD_DEVIATION 9.8 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
12 Participants
n=6 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
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
26 Participants
n=6 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
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
26 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (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
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 12 monthsPopulation: DLT evaluble population included participants who completed the DLT window without a DLT, or participants who reported with a DLT.
Number of participants with DLTs.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=3 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=13 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=5 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
1 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 60 days after last dose of study treatment (up to approximately 12 months)Population: Safety population included all participants enrolled in the study who received at least one dose of study treatment.
Percentage of participants with adverse events.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=3 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=13 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=5 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 following single dose administration of RO7172508Population: Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=4 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=13 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=5 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Maximum Concentration of RO7172508
Baseline sCEA >20 ng/mL
|
—
|
—
|
—
|
85.0 ng/mL
Geometric Coefficient of Variation 17.3
|
184 ng/mL
Geometric Coefficient of Variation 167
|
290 ng/mL
Geometric Coefficient of Variation 2.9
|
1180 ng/mL
|
|
Maximum Concentration of RO7172508
Baseline sCEA <=20 ng/mL
|
—
|
9.19 ng/mL
|
21.5 ng/mL
|
73.3 ng/mL
Geometric Coefficient of Variation 54.4
|
252 ng/mL
Geometric Coefficient of Variation 138
|
370 ng/mL
Geometric Coefficient of Variation 29.2
|
937 ng/mL
|
SECONDARY outcome
Timeframe: Cycle 1 following single dose administration of RO7172508Population: Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=4 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=13 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=5 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Time of Maximum Concentration of RO7172508
Baseline sCEA <=20 ng/mL
|
—
|
2.58 Hour
|
2.07 Hour
|
3.30 Hour
Interval 2.2 to 4.4
|
3.79 Hour
Interval 1.8 to 4.1
|
2.13 Hour
Interval 2.1 to 3.8
|
4.48 Hour
|
|
Time of Maximum Concentration of RO7172508
Baseline sCEA >20 ng/mL
|
—
|
—
|
—
|
2.16 Hour
Interval 2.16 to 2.16
|
2.18 Hour
Interval 2.0 to 4.3
|
3.09 Hour
Interval 2.0 to 4.2
|
1.95 Hour
|
SECONDARY outcome
Timeframe: Cycle 1 following single dose administration of RO7172508Population: Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=3 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=8 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=4 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Clearance or Apparent Clearance of RO7172508
Baseline sCEA >20 ng/mL
|
—
|
—
|
—
|
453 mL/hr
|
340 mL/hr
Geometric Coefficient of Variation 527
|
68.8 mL/hr
|
39.3 mL/hr
|
|
Clearance or Apparent Clearance of RO7172508
Baseline sCEA <=20 ng/mL
|
—
|
332 mL/hr
|
NA mL/hr
Not determined because
λz was not estimable.
|
111 mL/hr
Geometric Coefficient of Variation 34.4
|
55.4 mL/hr
Geometric Coefficient of Variation 61.5
|
67.4 mL/hr
Geometric Coefficient of Variation 49.2
|
34.8 mL/hr
|
SECONDARY outcome
Timeframe: Cycle 1 following single dose administration of RO7172508Population: Analysis not conducted due to participants not reaching steady state due to early withdrawal or loss of exposure due to immunogenicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 following single dose administration of RO7172508Population: Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=4 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=13 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=5 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time-Curve From Zero to the Last Measured Concentration (AUClast) of RO7172508
Baseline sCEA <=20 ng/mL
|
—
|
6.93 day*ng/mL
|
1.91 day*ng/mL
|
143 day*ng/mL
Geometric Coefficient of Variation 38.4
|
411 day*ng/mL
Geometric Coefficient of Variation 137
|
740 day*ng/mL
Geometric Coefficient of Variation 49.4
|
2140 day*ng/mL
|
|
Area Under the Plasma Concentration Time-Curve From Zero to the Last Measured Concentration (AUClast) of RO7172508
Baseline sCEA >20 ng/mL
|
—
|
—
|
—
|
45.4 day*ng/mL
Geometric Coefficient of Variation 34.4
|
83.5 day*ng/mL
Geometric Coefficient of Variation 178
|
370 day*ng/mL
Geometric Coefficient of Variation 121
|
1910 day*ng/mL
|
SECONDARY outcome
Timeframe: Cycle 1 following single dose administration of RO7172508Population: Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=3 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=8 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=4 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Versus Time Curve Computed From Time of Dosing to Infinity (AUCinf) of RO7172508
Baseline sCEA <=20 ng/mL
|
—
|
8.15 day*ng/mL
|
NA day*ng/mL
Not determined because
λz was not estimable.
|
150 day*ng/mL
Geometric Coefficient of Variation 34.7
|
602 day*ng/mL
Geometric Coefficient of Variation 61.7
|
740 day*ng/mL
Geometric Coefficient of Variation 49.2
|
2160 day*ng/mL
|
|
Area Under the Serum Concentration Versus Time Curve Computed From Time of Dosing to Infinity (AUCinf) of RO7172508
Baseline sCEA >20 ng/mL
|
—
|
—
|
—
|
36.8 day*ng/mL
|
98.1 day*ng/mL
Geometric Coefficient of Variation 527
|
727 day*ng/mL
|
1910 day*ng/mL
|
SECONDARY outcome
Timeframe: Cycle 1 following single dose administration of RO7172508Population: Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=3 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=8 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=4 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Dose Normalized Area Under the Serum Concentration Versus Time Curve Computed From Time of Dosing to Infinity (AUCinf/Dose) of RO7172508
Baseline sCEA <=20 ng/mL
|
—
|
125 day*ng/mL
|
NA day*ng/mL
Not determined because
λz was not estimable.
|
375 day*ng/mL
Geometric Coefficient of Variation 34.2
|
753 day*ng/mL
Geometric Coefficient of Variation 61.6
|
618 day*ng/mL
Geometric Coefficient of Variation 49.3
|
1200 day*ng/mL
|
|
Dose Normalized Area Under the Serum Concentration Versus Time Curve Computed From Time of Dosing to Infinity (AUCinf/Dose) of RO7172508
Baseline sCEA >20 ng/mL
|
—
|
—
|
—
|
92.0 day*ng/mL
|
122 day*ng/mL
Geometric Coefficient of Variation 526
|
606 day*ng/mL
|
1060 day*ng/mL
|
SECONDARY outcome
Timeframe: Cycle 1 following single dose administration of RO7172508Population: Pharmacokinetic population included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=3 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=8 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=4 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Half-Life of RO7172508
Baseline sCEA <=20 ng/mL
|
—
|
17.1 Hour
|
NA Hour
Not determined because
λz was not estimable.
|
54.0 Hour
Geometric Coefficient of Variation 112
|
62.1 Hour
Geometric Coefficient of Variation 42.4
|
40.9 Hour
Geometric Coefficient of Variation 68.9
|
48.7 Hour
|
|
Half-Life of RO7172508
Baseline sCEA >20 ng/mL
|
—
|
—
|
—
|
9.27 Hour
|
22.0 Hour
Geometric Coefficient of Variation 43.9
|
23.3 Hour
|
18.4 Hour
|
SECONDARY outcome
Timeframe: Up to approximately 12 monthsPopulation: Participants were considered as evaluable for immunogenicity analysis if they had at least 3 cycles of treatment to allow for development of potential ADAs.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=3 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=13 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=5 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Presence or Absence and Titer of ADAs
Presence of ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Presence or Absence and Titer of ADAs
Positive Titer
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)Population: Biopsies were not mandatory in part 1. Results from 2 participants are excluded as measured using a different assay.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=2 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=9 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=3 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Changes in Frequency of Tumor Infiltrating Lymphocytes
CD8 TIL Pre-treatment (Cycle 1 Day 1)
|
—
|
—
|
—
|
—
|
48.2 % of CD3
Interval 48.2 to 48.2
|
41.40 % of CD3
Interval 29.5 to 75.6
|
64.4 % of CD3
Interval 40.0 to 68.2
|
|
Changes in Frequency of Tumor Infiltrating Lymphocytes
CD8 TIL On-treatment (Cycle 2 Day 8)
|
—
|
—
|
—
|
—
|
54.15 % of CD3
Interval 51.2 to 57.1
|
54.7 % of CD3
Interval 38.0 to 78.4
|
52.75 % of CD3
Interval 35.4 to 70.1
|
|
Changes in Frequency of Tumor Infiltrating Lymphocytes
CD4 TIL Pre-treatment (Cycle 1 Day 1)
|
—
|
—
|
—
|
—
|
39.7 % of CD3
Interval 39.7 to 39.7
|
35.70 % of CD3
Interval 15.3 to 60.3
|
22.90 % of CD3
Interval 22.5 to 58.2
|
|
Changes in Frequency of Tumor Infiltrating Lymphocytes
CD4 TIL On-treatment (Cycle 2 Day 8)
|
—
|
—
|
—
|
—
|
35.00 % of CD3
Interval 32.8 to 37.2
|
33.80 % of CD3
Interval 2.4 to 54.9
|
42.65 % of CD3
Interval 29.9 to 55.4
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)Population: Biopsies were not mandatory in part 1. Results from 2 participants are excluded as measured using a different assay.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=2 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=9 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=3 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Secondary: Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD8)
CD8+CD25+ Pre-treatment (Cycle 1 Day 1)
|
—
|
—
|
—
|
—
|
22.00 % of CD8
Interval 22.0 to 22.0
|
17.60 % of CD8
Interval 3.3 to 89.9
|
9.70 % of CD8
Interval 9.1 to 29.5
|
|
Secondary: Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD8)
CD8+CD25+ On-treatment (Cycle 2 Day 8)
|
—
|
—
|
—
|
—
|
25.80 % of CD8
Interval 25.4 to 26.2
|
35.30 % of CD8
Interval 3.7 to 57.7
|
19.60 % of CD8
Interval 13.1 to 26.1
|
|
Secondary: Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD8)
CD8+CD279+ Pre-treatment (Cycle 1 Day 1)
|
—
|
—
|
—
|
—
|
11.90 % of CD8
Interval 11.9 to 11.9
|
8.70 % of CD8
Interval 2.3 to 70.8
|
11.40 % of CD8
Interval 6.2 to 72.3
|
|
Secondary: Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD8)
CD8+CD279+ On-treatment (Cycle 2 Day 8)
|
—
|
—
|
—
|
—
|
16.80 % of CD8
Interval 13.0 to 20.6
|
23.20 % of CD8
Interval 7.5 to 76.7
|
7.90 % of CD8
Interval 4.3 to 11.5
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)Population: Biopsies were not mandatory in part 1. Results from 2 participants are excluded as measured using a different assay.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=2 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=9 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=3 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD4)
CD4+CD25+ Pre-treatment (Cycle 1 Day 1)
|
—
|
—
|
—
|
—
|
51.9 % of CD4
Interval 51.9 to 51.9
|
41.20 % of CD4
Interval 11.4 to 86.8
|
26.90 % of CD4
Interval 20.6 to 34.4
|
|
Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD4)
CD4+CD25+ On-treatment (Cycle 2 Day 8)
|
—
|
—
|
—
|
—
|
47.35 % of CD4
Interval 42.3 to 52.4
|
47.65 % of CD4
Interval 12.0 to 51.8
|
30.75 % of CD4
Interval 11.5 to 50.0
|
|
Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD4)
CD4+CD279+ Pre-treatment (Cycle 1 Day 1)
|
—
|
—
|
—
|
—
|
16.50 % of CD4
Interval 16.5 to 16.5
|
10.90 % of CD4
Interval 1.8 to 43.8
|
16.80 % of CD4
Interval 4.0 to 32.8
|
|
Changes in Activation Status of Tumor Infiltrating Lymphocytes (% of CD4)
CD4+CD279+ On-treatment (Cycle 2 Day 8)
|
—
|
—
|
—
|
—
|
27.40 % of CD4
Interval 18.7 to 36.1
|
24.30 % of CD4
Interval 12.0 to 58.7
|
22.40 % of CD4
Interval 11.5 to 33.3
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-treatment), Cycle 2 Day 8 (Cycle is 21 days)Population: Paired included participant's with different dose and actual exposure levels. Data were pooled across all dose levels because the number of biopsy evaluable participants was overall small, and no dose/response relationship was found.
Spatial distribution of TIL's analyzed by performing IHC assay, which measures the density and intra-tumoral location of CD8+ T cells and reports "CD8 T cell immune phenotypes". These are classified as "desert", "excluded" and "inflamed".
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
n=2 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=2 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=9 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=4 Results
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Changes in Spatial Distribution of Tumor Infiltrating Lymphocytes
On-treatment (Cycle 2 Day 8) Excluded
|
—
|
—
|
—
|
—
|
0 CD8 immune phenotype
|
1 CD8 immune phenotype
|
2 CD8 immune phenotype
|
|
Changes in Spatial Distribution of Tumor Infiltrating Lymphocytes
On-treatment (Cycle 2 Day 8) Inflamed
|
—
|
—
|
—
|
—
|
0 CD8 immune phenotype
|
2 CD8 immune phenotype
|
1 CD8 immune phenotype
|
|
Changes in Spatial Distribution of Tumor Infiltrating Lymphocytes
Pre-treatment (Cycle 1 Day 1) Desert
|
0 CD8 immune phenotype
|
—
|
—
|
—
|
1 CD8 immune phenotype
|
5 CD8 immune phenotype
|
0 CD8 immune phenotype
|
|
Changes in Spatial Distribution of Tumor Infiltrating Lymphocytes
Pre-treatment (Cycle 1 Day 1) Excluded
|
1 CD8 immune phenotype
|
—
|
—
|
—
|
0 CD8 immune phenotype
|
0 CD8 immune phenotype
|
1 CD8 immune phenotype
|
|
Changes in Spatial Distribution of Tumor Infiltrating Lymphocytes
Pre-treatment (Cycle 1 Day 1) Inflamed
|
1 CD8 immune phenotype
|
—
|
—
|
—
|
0 CD8 immune phenotype
|
2 CD8 immune phenotype
|
1 CD8 immune phenotype
|
|
Changes in Spatial Distribution of Tumor Infiltrating Lymphocytes
On-treatment (Cycle 2 Day 8) Desert
|
—
|
—
|
—
|
—
|
2 CD8 immune phenotype
|
6 CD8 immune phenotype
|
1 CD8 immune phenotype
|
SECONDARY outcome
Timeframe: Up to approximately 12 monthsPopulation: Efficacy population included all participants who received at least one dose of RO7172508.
Objective response was defined as a Complete Response (CR) or Parital Response (PR), as determined by the Investigator's assessment using RECIST v1.1 and confirmed by repeat assessments \>= 4 weeks after initial documentation. To classify a response as SD, measurements are classified as stable (according to RECIST v1.1) at least once after study entry at a minimum of 6 weeks after study entry.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=3 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=13 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=5 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 12 monthsPopulation: Efficacy population included all participants who received at least one dose of RO7172508.
DCR is determined as the rate of participants with an observed tumor response of CR or PR (ORR) or CR, PR or SD (DCR). DCR is to be derived for RECIST v1.1.
Outcome measures
| Measure |
Part II: Multiple Participant Cohorts IV 1800 mcg
n=2 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
Part I: Single Participant Cohort IV RO7172508 65 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 160 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
Part I: Single Participant Cohort IV RO7172508 400 mcg
n=1 Participants
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
Part II: Multiple Participant Cohorts IV 400 mcg
n=3 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
Part II: Multiple Participant Cohorts IV 800 mcg
n=13 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
Part II: Multiple Participant Cohorts IV 1200 mcg
n=5 Participants
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 12 monthPopulation: Efficacy population included all participants who received at least one dose of RO7172508. DOR was not calculated because none of the participants had a response (complete or partial).
Among participants with an objective response (responders), DOR will be defined as the time from first occurrence of a documented objective response until the time of documented disease progression or death within 30 days from last study treatment from any cause during treatment, whichever occurs first. This will be calculated for participants who have a best overall response of CR or PR as defined per RECIST v1.1 and per iRECIST.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approxmately 12 monthsPopulation: Efficacy population included all participants who received at least one dose of RO7172508. PFS was not calculated because number of evaluable participants in each cohort respectively was too small to obtain reliable estimates for this endpoint.
PFS (on-treatment) will be defined as the time from study treatment initiation (Cycle 1 Day 1) to the first occurrence of documented disease progression or death from any cause during treatment (death within 30 days from last study treatment), whichever occurs first.
Outcome measures
Outcome data not reported
Adverse Events
PART1 - RO7172508 - Q3W - 65 mcg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
PART1 - RO7172508 - Q3W - 160 mcg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
PART1 - RO7172508 - Q3W - 400 mcg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
PART2 - RO7172508 - Q3W - 400 mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
PART2 - RO7172508 - Q3W - 800 mcg
Serious events: 8 serious events
Other events: 13 other events
Deaths: 8 deaths
PART2 - RO7172508 - Q3W - 1200 mcg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
PART2 - RO7172508 - Q3W - 1800 mcg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PART1 - RO7172508 - Q3W - 65 mcg
n=1 participants at risk
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
PART1 - RO7172508 - Q3W - 160 mcg
n=1 participants at risk
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
PART1 - RO7172508 - Q3W - 400 mcg
n=1 participants at risk
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
PART2 - RO7172508 - Q3W - 400 mcg
n=3 participants at risk
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
PART2 - RO7172508 - Q3W - 800 mcg
n=13 participants at risk
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
PART2 - RO7172508 - Q3W - 1200 mcg
n=5 participants at risk
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
PART2 - RO7172508 - Q3W - 1800 mcg
n=2 participants at risk
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
40.0%
2/5 • Number of events 4 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
Other adverse events
| Measure |
PART1 - RO7172508 - Q3W - 65 mcg
n=1 participants at risk
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 65 microgram (mcg).
|
PART1 - RO7172508 - Q3W - 160 mcg
n=1 participants at risk
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 160 microgram (mcg).
|
PART1 - RO7172508 - Q3W - 400 mcg
n=1 participants at risk
Part I was a multiple-ascending dose-escalation in single participant cohorts. RO7172508 was administered intravenously once every 3 weeks (Q3W) at a dose of 400 microgram (mcg).
|
PART2 - RO7172508 - Q3W - 400 mcg
n=3 participants at risk
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts: The starting-dose for the initiation of the IV dose-escalation was determined by Part I and RO7172508 was initially given Q3W. Starting dose of RO7172508 was 400 mcg.
|
PART2 - RO7172508 - Q3W - 800 mcg
n=13 participants at risk
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 800 mcg.
|
PART2 - RO7172508 - Q3W - 1200 mcg
n=5 participants at risk
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1200 mcg.
|
PART2 - RO7172508 - Q3W - 1800 mcg
n=2 participants at risk
Part II was a multiple ascending dose-escalation of IV-administered RO7172508 in multiple participant cohorts. RO7172508 was administered intravenously at a dose of 1800 mcg.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Infusion site extravasation
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Oedema
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
46.2%
6/13 • Number of events 12 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
40.0%
2/5 • Number of events 4 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Eye disorders
Episcleritis
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Eye disorders
Eye haematoma
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
38.5%
5/13 • Number of events 6 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
40.0%
2/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 6 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
60.0%
3/5 • Number of events 5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
2/2 • Number of events 4 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 7 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
60.0%
3/5 • Number of events 6 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 8 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
60.0%
3/5 • Number of events 11 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
40.0%
2/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Chills
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Early satiety
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 4 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
40.0%
2/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
2/2 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
40.0%
2/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Intercepted medication error
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Body temperature increased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
38.5%
5/13 • Number of events 5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
60.0%
3/5 • Number of events 4 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
2/2 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
40.0%
2/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
1/2 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
40.0%
2/5 • Number of events 3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/13 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/2 • Baseline up to approximately 12 months
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER