Trial Outcomes & Findings for A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors (NCT NCT03717415)
NCT ID: NCT03717415
Last Updated: 2024-12-27
Results Overview
Number of participants who experienced serious adverse events (SAE) and adverse events (AE).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Baseline up to 2.32 years
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
Dose escalation with rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in 21-day cycles in combination with carboplatin administered by intravenous (IV) infusion at area under the curve (AUC)5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in triple-negative breast cancer (TNBC) participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
14
|
5
|
9
|
2
|
18
|
2
|
6
|
11
|
|
Overall Study
mITT Population
|
3
|
12
|
5
|
9
|
2
|
18
|
2
|
6
|
11
|
|
Overall Study
COMPLETED
|
3
|
7
|
0
|
4
|
0
|
12
|
0
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
5
|
5
|
2
|
6
|
2
|
3
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=3 Participants
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=14 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=5 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=9 Participants
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=18 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=6 Participants
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=11 Participants
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
43 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
53 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
61 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
65 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
14 participants
n=7 Participants
|
5 participants
n=5 Participants
|
9 participants
n=4 Participants
|
2 participants
n=21 Participants
|
18 participants
n=8 Participants
|
2 participants
n=8 Participants
|
6 participants
n=24 Participants
|
11 participants
n=42 Participants
|
70 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 2.32 yearsPopulation: All participants who received any study drug.
Number of participants who experienced serious adverse events (SAE) and adverse events (AE).
Outcome measures
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=3 Participants
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=14 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=5 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=9 Participants
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=18 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=6 Participants
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=11 Participants
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any SAE
|
2 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events
Any AE
|
3 Participants
|
13 Participants
|
5 Participants
|
9 Participants
|
2 Participants
|
18 Participants
|
2 Participants
|
6 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)Population: Expansion Phase mITT participants that were evaluable for this outcome measure.
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Outcome measures
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=9 Participants
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=18 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=6 Participants
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=11 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) (Dose Expansion Phase)
|
0 percentage of participants
Interval 0.0 to 28.3
|
0 percentage of participants
Interval 0.0 to 77.6
|
16.7 percentage of participants
Interval 4.7 to 37.7
|
100 percentage of participants
Interval 22.4 to 100.0
|
0 percentage of participants
Interval 0.0 to 39.3
|
0 percentage of participants
Interval 0.0 to 23.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from CR or PR to disease progression or death due to any cause (Up to 1.53 years)Population: Escalation Phase mITT participants that were evaluable for this outcome measure.
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Outcome measures
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=3 Participants
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=12 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=5 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) (Dose Escalation Phase)
|
0 percentage of participants
Interval 0.0 to 63.2
|
0 percentage of participants
Interval 0.0 to 22.1
|
0 percentage of participants
Interval 0.0 to 45.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from PR or CR to PD or Death due to Any Cause (up to 1.53 years)Population: mITT participants that had CR or PR and were evaluable for this outcome measure.
Time from first partial response (PR) or complete response (CR) to disease progression (PD) or death due to any cause. Evaluation of radiographic disease assessment per Response Evaluation Criteria in Solid Tumor (RECIST v1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Outcome measures
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=3 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
—
|
—
|
—
|
—
|
11.8 months
The 90% Confidence Interval (CI) was not estimable due to insufficient number of events.
|
13.5 months
Interval 8.6 to
The 90% CI was not estimable due to insufficient number of events.
|
—
|
—
|
SECONDARY outcome
Timeframe: First Dose of Study Drug to PD (Up to 1.63 years)Population: mITT participants that were evaluable for this outcome measure.
Time from first dose of study drug to the first documentation of progressive disease (PD). Participants were considered to have progressive disease if they had documented progression based on radiologic assessment according to RECIST v1.1. RECIST v1.1 defined disease progression as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=2 Participants
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=6 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=4 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=7 Participants
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=11 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=6 Participants
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP)
|
1.4 months
Interval 0.9 to
The 90% CI was not estimable due to insufficient number of events.
|
4.0 months
Interval 1.4 to
The 90% CI was not estimable due to insufficient number of events.
|
2.3 months
Interval 1.2 to
The 90% CI was not estimable due to insufficient number of events.
|
1.5 months
Interval 1.1 to 3.2
|
1.3 months
Interval 1.2 to
The 90% CI was not estimable due to insufficient number of events.
|
6.7 months
Interval 4.6 to 13.3
|
14.6 months
Interval 9.8 to
The 90% CI was not estimable due to insufficient number of events.
|
NA months
Interval 4.5 to
TTP median and 90% CI were not estimable due to insufficient number of events.
|
4.9 months
Interval 3.2 to
The 90% CI was not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: First Dose of Study Drug to PD or Death due to Any Cause (up to 1.63 years)Population: mITT participants that were evaluable for this outcome measure.
Time from first dose of study drug to disease progression (PD) or death due to any cause. Participants who undergo surgical resection of target or non-target lesions, who have received other anticancer treatments, including surgical resection or radiation (other than palliative radiation to pre-existing bone metastases'), or who do not have a documented date of progression or death due to any cause will be censored at the date of the last assessment. Disease progression per RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Outcome measures
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=3 Participants
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=12 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=5 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=9 Participants
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=18 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=6 Participants
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=11 Participants
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression-free-survival (PFS)
|
1.4 months
Interval 0.9 to
The 90% CI was not estimable due to insufficient number of events.
|
4.0 months
Interval 1.4 to
The 90% CI was not estimable due to insufficient number of events.
|
2.3 months
Interval 1.2 to
The 90% CI was not estimable due to insufficient number of events.
|
1.5 months
Interval 1.1 to 3.2
|
1.3 months
Interval 1.2 to
The 90% CI was not estimable due to insufficient number of events.
|
6.7 months
Interval 4.6 to 13.3
|
14.6 months
Interval 9.8 to
The 90% CI was not estimable due to insufficient number of events.
|
NA months
Interval 4.5 to
PFS median and 90% CI were not estimable due to insufficient number of events.
|
4.8 months
Interval 3.2 to 6.5
|
SECONDARY outcome
Timeframe: Baseline to death due to any cause (Up to 2.12 years)Population: mITT participants that were evaluable for this outcome measure.
Time from baseline C1 D1 to date of death due to any cause. Participants who are still alive or who are lost to follow-up will be censored at the date of last contact.
Outcome measures
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=3 Participants
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=12 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=5 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=9 Participants
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=18 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 Participants
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=6 Participants
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=11 Participants
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA months
OS median and 90% CI were not estimable due to insufficient number of events.
|
NA months
OS median and 90% CI were not estimable due to insufficient number of events.
|
NA months
Interval 1.8 to
OS median and 90% CI were not estimable due to insufficient number of events.
|
NA months
OS median and 90% CI were not estimable due to insufficient number of events.
|
NA months
OS median and 90% CI were not estimable due to insufficient number of events.
|
NA months
OS median and 90% CI were not estimable due to insufficient number of events.
|
NA months
OS median and 90% CI were not estimable due to insufficient number of events.
|
NA months
OS median and 90% CI were not estimable due to insufficient number of events.
|
9.9 months
Interval 4.0 to
The 90% CI was not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)Population: Part 1 participants who received any study drug and had evaluable Cmax data at each timepoint.
Cmax of rebastinib
Outcome measures
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=3 Participants
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=13 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=3 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
C1 D1
|
92.2 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 157
|
120 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 106
|
144 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 103
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
C2 D1
|
190 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 106
|
151 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 67.8
|
323 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Cycle (C) 1 Day (D) 1, C2 D1 (Cycle = 21 Days)Population: Part 1 participants who received any study drug and had evaluable AUC data at each timepoint.
Measure the AUC 0-3 hours
Outcome measures
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=3 Participants
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=13 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=3 Participants
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration-time Curve 0-3 Hours (AUC 0-3 Hours) (Part 1)
C1 D1
|
186 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 153
|
150 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 125
|
230 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 116
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK: Area Under the Concentration-time Curve 0-3 Hours (AUC 0-3 Hours) (Part 1)
C2 D1
|
380 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 88.3
|
262 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 103
|
369 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 98.7
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
Serious events: 6 serious events
Other events: 11 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=3 participants at risk
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=14 participants at risk
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=5 participants at risk
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=9 participants at risk
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 participants at risk
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=18 participants at risk
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 participants at risk
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=6 participants at risk
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=11 participants at risk
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Eye disorders
Retinal vascular disorder
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 2 • Baseline up to 2.32 years
|
|
General disorders
Asthenia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
General disorders
Death
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Surgical and medical procedures
Wound treatment
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 2 • Baseline up to 2.32 years
|
Other adverse events
| Measure |
Part 1 Cohort 1 Escalation Rebastinib 50 mg + Carboplatin AUC5
n=3 participants at risk
Dose escalation with rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 2 Escalation Rebastinib 100 mg + Carboplatin AUC5
n=14 participants at risk
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 1 Cohort 3 Escalation Rebastinib 100 mg + Carboplatin AUC6
n=5 participants at risk
Dose escalation with rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC6 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=9 participants at risk
Dose expansion in TNBC participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 1 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 participants at risk
Dose expansion in TNBC participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=18 participants at risk
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 2 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=2 participants at risk
Dose expansion in platinum-sensitive ovarian cancer participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 50 mg + Carboplatin AUC5
n=6 participants at risk
Dose expansion in mesothelioma participants. Rebastinib 50 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
Part 2 Cohort 3 Expansion Rebastinib 100 mg + Carboplatin AUC5
n=11 participants at risk
Dose expansion in mesothelioma participants. Rebastinib 100 mg BID PO in 21-day cycles in combination with carboplatin administered by IV infusion at AUC5 at Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
21.4%
3/14 • Number of events 4 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
3/18 • Number of events 5 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
18.2%
2/11 • Number of events 5 • Baseline up to 2.32 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Baseline up to 2.32 years
|
14.3%
2/14 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 2 • Baseline up to 2.32 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 2 • Baseline up to 2.32 years
|
35.7%
5/14 • Number of events 9 • Baseline up to 2.32 years
|
40.0%
2/5 • Number of events 2 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Cardiac disorders
Conduction disorder
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Eye disorders
Borderline glaucoma
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
3/18 • Number of events 3 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Eye disorders
Photopsia
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Eye disorders
Refraction disorder
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Eye disorders
Retinal tear
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Baseline up to 2.32 years
|
14.3%
2/14 • Number of events 2 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 3 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 2 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Baseline up to 2.32 years
|
14.3%
2/14 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
27.8%
5/18 • Number of events 5 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Baseline up to 2.32 years
|
35.7%
5/14 • Number of events 5 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
50.0%
9/18 • Number of events 11 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
66.7%
4/6 • Number of events 5 • Baseline up to 2.32 years
|
27.3%
3/11 • Number of events 5 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
22.2%
4/18 • Number of events 8 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
18.2%
2/11 • Number of events 5 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 2 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
33.3%
6/18 • Number of events 6 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
14.3%
2/14 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
16.7%
3/18 • Number of events 4 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Baseline up to 2.32 years
|
21.4%
3/14 • Number of events 4 • Baseline up to 2.32 years
|
40.0%
2/5 • Number of events 2 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
38.9%
7/18 • Number of events 9 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.32 years
|
54.5%
6/11 • Number of events 6 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
3/18 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
38.9%
7/18 • Number of events 7 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.32 years
|
45.5%
5/11 • Number of events 6 • Baseline up to 2.32 years
|
|
General disorders
Asthenia
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
General disorders
Chills
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
21.4%
3/14 • Number of events 5 • Baseline up to 2.32 years
|
40.0%
2/5 • Number of events 3 • Baseline up to 2.32 years
|
66.7%
6/9 • Number of events 6 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
61.1%
11/18 • Number of events 17 • Baseline up to 2.32 years
|
100.0%
2/2 • Number of events 3 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
45.5%
5/11 • Number of events 7 • Baseline up to 2.32 years
|
|
General disorders
Feeling jittery
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
33.3%
3/9 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
3/18 • Number of events 5 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 2 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Number of events 2 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 2 • Baseline up to 2.32 years
|
100.0%
2/2 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
18.2%
2/11 • Number of events 2 • Baseline up to 2.32 years
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
Pustule
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 2 • Baseline up to 2.32 years
|
100.0%
2/2 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
18.2%
2/11 • Number of events 3 • Baseline up to 2.32 years
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
22.2%
4/18 • Number of events 5 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Baseline up to 2.32 years
|
14.3%
2/14 • Number of events 2 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 3 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Baseline up to 2.32 years
|
14.3%
2/14 • Number of events 2 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 2 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 2 • Baseline up to 2.32 years
|
18.2%
2/11 • Number of events 3 • Baseline up to 2.32 years
|
|
Investigations
Blood lactate dehydrogenase decreased
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/3 • Baseline up to 2.32 years
|
14.3%
2/14 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
33.3%
6/18 • Number of events 7 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Baseline up to 2.32 years
|
21.4%
3/14 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
27.8%
5/18 • Number of events 9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 5 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
50.0%
9/18 • Number of events 34 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.32 years
|
18.2%
2/11 • Number of events 3 • Baseline up to 2.32 years
|
|
Investigations
Weight increased
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
27.3%
3/11 • Number of events 5 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
3/18 • Number of events 3 • Baseline up to 2.32 years
|
100.0%
2/2 • Number of events 4 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 6 • Baseline up to 2.32 years
|
100.0%
2/2 • Number of events 3 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 2 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
40.0%
2/5 • Number of events 3 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
100.0%
2/2 • Number of events 3 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
22.2%
2/9 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
3/18 • Number of events 3 • Baseline up to 2.32 years
|
100.0%
2/2 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 2 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 2 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
3/18 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Baseline up to 2.32 years
|
21.4%
3/14 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
16.7%
3/18 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
18.2%
2/11 • Number of events 2 • Baseline up to 2.32 years
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Baseline up to 2.32 years
|
21.4%
3/14 • Number of events 5 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 2 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 4 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
22.2%
2/9 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
27.8%
5/18 • Number of events 7 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
18.2%
2/11 • Number of events 2 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
22.2%
2/9 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
3/18 • Number of events 3 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
18.2%
2/11 • Number of events 2 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Baseline up to 2.32 years
|
7.1%
1/14 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
22.2%
4/18 • Number of events 4 • Baseline up to 2.32 years
|
100.0%
2/2 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
50.0%
1/2 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
11.1%
2/18 • Number of events 3 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Baseline up to 2.32 years
|
14.3%
2/14 • Number of events 2 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
11.1%
1/9 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/18 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
9.1%
1/11 • Number of events 1 • Baseline up to 2.32 years
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/3 • Baseline up to 2.32 years
|
0.00%
0/14 • Baseline up to 2.32 years
|
0.00%
0/5 • Baseline up to 2.32 years
|
0.00%
0/9 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
5.6%
1/18 • Number of events 1 • Baseline up to 2.32 years
|
0.00%
0/2 • Baseline up to 2.32 years
|
0.00%
0/6 • Baseline up to 2.32 years
|
0.00%
0/11 • Baseline up to 2.32 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place