Trial Outcomes & Findings for DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease (NCT NCT04420598)
NCT ID: NCT04420598
Last Updated: 2025-06-24
Results Overview
This outcome measure evaluates progression-free survival (PFS) in Cohort 1 over a 16-week period, using the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
From baseline up to 16 weeks
Results posted on
2025-06-24
Participant Flow
Participant milestones
| Measure |
Cohort 1
•Cohort 1: HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 2
• Cohort 2: HER2-positive or HER2-low BC with asymptomatic untreated BM;
|
Cohort 3
• Cohort 3: HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
9
|
6
|
7
|
|
Overall Study
COMPLETED
|
3
|
3
|
1
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
8
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=8 Participants
•Cohort 1: HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 2
n=10 Participants
• Cohort 2: HER2-positive or HER2-low BC with asymptomatic untreated BM;
|
Cohort 3
n=9 Participants
• Cohort 3: HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
n=6 Participants
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
n=7 Participants
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Previous early disease treatment
Therapeutic radiopharmaceuticals
|
3 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=40 Participants
|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 10.4 • n=8 Participants
|
53.4 years
STANDARD_DEVIATION 13.5 • n=10 Participants
|
50.2 years
STANDARD_DEVIATION 8.8 • n=9 Participants
|
61.0 years
STANDARD_DEVIATION 9.5 • n=6 Participants
|
52.7 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 11.0 • n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=8 Participants
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
40 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ECOG
0
|
5 Participants
n=8 Participants
|
9 Participants
n=10 Participants
|
6 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
24 Participants
n=40 Participants
|
|
ECOG
1
|
3 Participants
n=8 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=40 Participants
|
|
ECOG
2
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=40 Participants
|
|
Measurable disease at screening
No
|
3 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=40 Participants
|
|
Measurable disease at screening
Yes
|
5 Participants
n=8 Participants
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
33 Participants
n=40 Participants
|
|
Number of metastatic organ sites
1
|
4 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=40 Participants
|
|
Number of metastatic organ sites
2
|
1 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=40 Participants
|
|
Number of metastatic organ sites
3
|
2 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=40 Participants
|
|
Number of metastatic organ sites
4
|
0 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=40 Participants
|
|
Number of metastatic organ sites
5
|
1 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=40 Participants
|
|
Number of metastatic organ sites
6
|
0 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=40 Participants
|
|
Number of metastatic organ sites
7
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=40 Participants
|
|
HER2 IHC test
0
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=40 Participants
|
|
HER2 IHC test
1+
|
0 Participants
n=8 Participants
|
5 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=40 Participants
|
|
HER2 IHC test
2+
|
2 Participants
n=8 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=40 Participants
|
|
HER2 IHC test
3+
|
6 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=40 Participants
|
|
HER2 status
Positive
|
8 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
24 Participants
n=40 Participants
|
|
HER2 status
Low expressing
|
0 Participants
n=8 Participants
|
6 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=40 Participants
|
|
HER2 status
Negative
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=40 Participants
|
|
HER2 status
Indeterminate
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=40 Participants
|
|
Estrogen receptor status
Negative
|
4 Participants
n=8 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=40 Participants
|
|
Previous early disease treatment
Immunosuppressants
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=40 Participants
|
|
Estrogen receptor status
Positive
|
4 Participants
n=8 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
26 Participants
n=40 Participants
|
|
Progesterone receptor status
Negative
|
2 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=40 Participants
|
|
Progesterone receptor status
Positive
|
6 Participants
n=8 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
27 Participants
n=40 Participants
|
|
Hormone receptor status
Negative
|
1 Participants
n=8 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=40 Participants
|
|
Hormone receptor status
Positive
|
7 Participants
n=8 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
30 Participants
n=40 Participants
|
|
Number of previous early disease treatment lines
0
|
2 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=40 Participants
|
|
Number of previous early disease treatment lines
1
|
0 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=40 Participants
|
|
Number of previous early disease treatment lines
2
|
1 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=40 Participants
|
|
Number of previous early disease treatment lines
3
|
3 Participants
n=8 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=40 Participants
|
|
Number of previous early disease treatment lines
4
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=40 Participants
|
|
Number of previous early disease treatment lines
5
|
1 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=40 Participants
|
|
Number of previous early disease treatment lines
6
|
1 Participants
n=8 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=40 Participants
|
|
Number of previous early disease treatment lines
|
2.8 Number of previous early disease treatm
STANDARD_DEVIATION 2.1 • n=8 Participants
|
1.5 Number of previous early disease treatm
STANDARD_DEVIATION 1.9 • n=10 Participants
|
1.7 Number of previous early disease treatm
STANDARD_DEVIATION 1.6 • n=9 Participants
|
1.3 Number of previous early disease treatm
STANDARD_DEVIATION 0.8 • n=6 Participants
|
3.0 Number of previous early disease treatm
STANDARD_DEVIATION 1.0 • n=7 Participants
|
2.0 Number of previous early disease treatm
STANDARD_DEVIATION 1.7 • n=40 Participants
|
|
Previous early disease treatment line
No
|
2 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=40 Participants
|
|
Previous early disease treatment line
Yes
|
6 Participants
n=8 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
30 Participants
n=40 Participants
|
|
Previous early disease treatment
Antineoplastic agents
|
6 Participants
n=8 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
29 Participants
n=40 Participants
|
|
Previous early disease treatment
Endocrine therapy
|
3 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=40 Participants
|
|
Previous lines in advanced disease
1
|
2 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=40 Participants
|
|
Previous lines in advanced disease
2
|
2 Participants
n=8 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=40 Participants
|
|
Previous lines in advanced disease
3
|
1 Participants
n=8 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=40 Participants
|
|
Previous lines in advanced disease
4
|
1 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=40 Participants
|
|
Previous lines in advanced disease
5
|
1 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=40 Participants
|
|
Previous lines in advanced disease
6
|
0 Participants
n=8 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=40 Participants
|
|
Previous lines in advanced disease
7
|
0 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=40 Participants
|
|
Previous lines in advanced disease
8
|
1 Participants
n=8 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=40 Participants
|
|
Previous lines in advanced disease
9
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=40 Participants
|
|
Previous lines in advanced disease
10
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=40 Participants
|
|
Previous lines in advanced disease
11
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=40 Participants
|
|
Previous lines in advanced disease
12
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=40 Participants
|
|
Previous lines in advanced disease
13
|
0 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=40 Participants
|
|
Previous advanced/ metastatic disease systemic treatment lines
|
8 Participants
n=8 Participants
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
40 Participants
n=40 Participants
|
|
Previous systematic cancer therapy
Trastuzumab
|
7 Participants
n=8 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
23 Participants
n=40 Participants
|
|
Previous systematic cancer therapy
Trastuzumab emtansine
|
4 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=40 Participants
|
|
Previous systematic cancer therapy
Pertuzumab
|
7 Participants
n=8 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=40 Participants
|
|
Previous systematic cancer therapy
Other anti-HER2 therapy
|
3 Participants
n=8 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=40 Participants
|
|
Previous systematic cancer therapy
Endocrine therapy
|
3 Participants
n=8 Participants
|
7 Participants
n=10 Participants
|
4 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
21 Participants
n=40 Participants
|
|
Previous systematic cancer therapy
LHRH agonist therapy
|
1 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=40 Participants
|
|
Previous systematic cancer therapy
Complete or partial response
|
2 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=40 Participants
|
|
Previous systematic cancer therapy
Stable disease
|
2 Participants
n=8 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=40 Participants
|
|
Previous systematic cancer therapy
Disease progression
|
2 Participants
n=8 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=40 Participants
|
|
Previous systematic cancer therapy
Could not be elevated
|
2 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 16 weeksPopulation: This outcome measure was the primary endpoint evaluated exclusively in Cohort 1. Therefore, results are only reported for the participants in this cohort.
This outcome measure evaluates progression-free survival (PFS) in Cohort 1 over a 16-week period, using the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 3
HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 4
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
|---|---|---|---|---|---|
|
16 Weeks PFS Per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) (Cohort 1)
With PFS at 16 weeks
|
1 Participants
|
—
|
—
|
—
|
—
|
|
16 Weeks PFS Per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) (Cohort 1)
Without PFS at 16 weeks
|
7 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.Population: This outcome measure was assessed only in Cohorts 2, 3, and 4. Therefore, data for Cohorts 1 and 5 are not included in this measure
The proportion of patients achieving either Complete Response (CR) or Partial Response (PR) at any assessment time point, based on Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria
Outcome measures
| Measure |
Cohort 1
n=10 Participants
HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 3
n=9 Participants
HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
n=6 Participants
HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 4
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
|---|---|---|---|---|---|
|
Objective Response Rate According RANO-BM (Cohorts 2, 3 and 4)
No
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Objective Response Rate According RANO-BM (Cohorts 2, 3 and 4)
Yes
|
7 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.Population: Overall survival the primary outcome measure only in Cohort 5. Therefore, data for other cohorts are not included in this outcome measure.
Median of OS rate for patients
Outcome measures
| Measure |
Cohort 1
n=7 Participants
HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 3
HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 4
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
|---|---|---|---|---|---|
|
Overall Survival in Cohort 5
|
13.3 months
Interval 2.5 to
Not enough events occurred after the median to calculate the top interval
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.Population: Patients that have at least one CNS lesion
Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
Outcome measures
| Measure |
Cohort 1
n=4 Participants
HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 3
n=10 Participants
HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
n=9 Participants
HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 4
n=6 Participants
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
n=5 Participants
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
|---|---|---|---|---|---|
|
Intra-cranial Evaluation According to RANO-BM
CR
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Intra-cranial Evaluation According to RANO-BM
PR
|
0 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Intra-cranial Evaluation According to RANO-BM
SD≥24w
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Intra-cranial Evaluation According to RANO-BM
SD<24w
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Intra-cranial Evaluation According to RANO-BM
PD
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.Population: Patients that had at least one non-CNS lesion
This outcome measure assesses the extra-cranial response of metastatic lesions outside the brain using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 3
n=10 Participants
HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
n=5 Participants
HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 4
n=6 Participants
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
n=6 Participants
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
|---|---|---|---|---|---|
|
Extra-cranial Evaluation According to RECIST v1.1
PR
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Extra-cranial Evaluation According to RECIST v1.1
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Extra-cranial Evaluation According to RECIST v1.1
SD ≥24 weeks
|
2 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
|
Extra-cranial Evaluation According to RECIST v1.1
SD <24 weeks
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Extra-cranial Evaluation According to RECIST v1.1
PD
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.Population: Patients with at least one CNS and non-CNS lesion
The global evaluation of tumor response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. This includes classification into categories such as Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD), based on changes in tumor size and the appearance of new lesions.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 3
n=10 Participants
HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
n=9 Participants
HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 4
n=6 Participants
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
n=7 Participants
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
|---|---|---|---|---|---|
|
Global Evaluation According to RECIST v1.1
PR
|
4 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Global Evaluation According to RECIST v1.1
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Global Evaluation According to RECIST v1.1
SD ≥24
|
3 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Global Evaluation According to RECIST v1.1
SD <24
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Global Evaluation According to RECIST v1.1
PD
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.The Clinical Benefit Rate (CBR) is a measure of the proportion of patients who achieve a clinically meaningful benefit from the treatment
Outcome measures
| Measure |
Cohort 1
n=8 Participants
HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 3
n=10 Participants
HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
n=9 Participants
HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 4
n=6 Participants
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
n=7 Participants
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
|---|---|---|---|---|---|
|
Unconfirmed Clinical Benefit Rate According to RANO-BM and RECIST v1.1
Yes
|
7 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Unconfirmed Clinical Benefit Rate According to RANO-BM and RECIST v1.1
No
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 4 deaths
Cohort 2
Serious events: 1 serious events
Other events: 10 other events
Deaths: 5 deaths
Cohort 3
Serious events: 5 serious events
Other events: 8 other events
Deaths: 6 deaths
Cohort 4
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Cohort 5
Serious events: 4 serious events
Other events: 7 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort 1
n=8 participants at risk
•Cohort 1: HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 2
n=10 participants at risk
• Cohort 2: HER2-positive or HER2-low BC with asymptomatic untreated BM;
|
Cohort 3
n=9 participants at risk
• Cohort 3: HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
n=6 participants at risk
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
n=7 participants at risk
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Superinfection
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
Other adverse events
| Measure |
Cohort 1
n=8 participants at risk
•Cohort 1: HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.);
|
Cohort 2
n=10 participants at risk
• Cohort 2: HER2-positive or HER2-low BC with asymptomatic untreated BM;
|
Cohort 3
n=9 participants at risk
• Cohort 3: HER2-positive BC with progressing BMs after local treatment;
|
Cohort 4
n=6 participants at risk
• Cohort 4: HER2-low expressing BC with progressing BMs after local treatment;
|
Cohort 5
n=7 participants at risk
• Cohort 5: HER2-positive or HER2-low expressing BC with LMC.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Adenoviral upper respiratory infection
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
20.0%
2/10 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
22.2%
2/9 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Number of events 13 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
70.0%
7/10 • Number of events 21 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
33.3%
3/9 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
50.0%
3/6 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
57.1%
4/7 • Number of events 6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
2/8 • Number of events 9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
40.0%
4/10 • Number of events 4 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
44.4%
4/9 • Number of events 13 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Paraesthesia
|
25.0%
2/8 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Proctalgia
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
20.0%
2/10 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
SARS-CoV-2 test positive
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
2/8 • Number of events 10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
20.0%
2/10 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
28.6%
2/7 • Number of events 5 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
20.0%
2/10 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
33.3%
3/9 • Number of events 5 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
42.9%
3/7 • Number of events 14 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Eye disorders
Vision blurred
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
50.0%
5/10 • Number of events 13 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
22.2%
2/9 • Number of events 6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
42.9%
3/7 • Number of events 5 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
40.0%
4/10 • Number of events 5 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.5%
3/8 • Number of events 4 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
40.0%
4/10 • Number of events 6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
44.4%
4/9 • Number of events 6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
33.3%
2/6 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
42.9%
3/7 • Number of events 4 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
2/8 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
50.0%
5/10 • Number of events 8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
40.0%
4/10 • Number of events 4 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
33.3%
2/6 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
30.0%
3/10 • Number of events 4 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
22.2%
2/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Constipation
|
62.5%
5/8 • Number of events 9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
30.0%
3/10 • Number of events 4 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
22.2%
2/9 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
33.3%
2/6 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
28.6%
2/7 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
40.0%
4/10 • Number of events 5 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
33.3%
3/9 • Number of events 6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
20.0%
2/10 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
28.6%
2/7 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
General disorders
Fatigue
|
75.0%
6/8 • Number of events 11 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
90.0%
9/10 • Number of events 24 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
44.4%
4/9 • Number of events 10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
83.3%
5/6 • Number of events 6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
42.9%
3/7 • Number of events 4 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
General disorders
Gait disturbance
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
30.0%
3/10 • Number of events 4 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
33.3%
2/6 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
28.6%
2/7 • Number of events 5 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
30.0%
3/10 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
22.2%
2/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
42.9%
3/7 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Vascular disorders
Hot flush
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
22.2%
2/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
General disorders
Chest pain
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
General disorders
Discomfort
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Dysentery
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
20.0%
2/10 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Ear infection
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
20.0%
2/10 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
20.0%
2/10 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
20.0%
2/10 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
33.3%
2/6 • Number of events 6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Urinary sediment abnormal
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
White blood cell count increased
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
10.0%
1/10 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Eye disorders
Diplopia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
28.6%
2/7 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
22.2%
2/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
33.3%
3/9 • Number of events 3 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
General disorders
Oedema
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
22.2%
2/9 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
11.1%
1/9 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
General disorders
Pain
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Investigations
Transaminases increased
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
16.7%
1/6 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/7 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Surgical and medical procedures
Central venous catheter removal
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
General disorders
Infusion site thrombosis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
General disorders
Loss of control of legs
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 2 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Paresis
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/8 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/10 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/9 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
0.00%
0/6 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
14.3%
1/7 • Number of events 1 • Each participant was assessed from baseline until the last tumor response evaluation, up to 16 months.
|
Additional Information
Alicia García Sanz PhD
Medica Scientia Innovation Research (Medsir)
Phone: 611261467
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place