Trial Outcomes & Findings for A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors (NCT NCT03601897)
NCT ID: NCT03601897
Last Updated: 2024-12-27
Results Overview
Number of participants (pts) who experienced serious adverse events (SAE) and adverse events (AE).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
177 participants
Primary outcome timeframe
Baseline up to 2.89 years
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in combination with paclitaxel administered by intravenous (IV) infusion at 80 mg/meter squared (m\^2) on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in triple-negative breast cancer (TNBC). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
19
|
12
|
6
|
15
|
5
|
28
|
10
|
22
|
16
|
20
|
|
Overall Study
mITT Population
|
18
|
14
|
10
|
6
|
13
|
4
|
26
|
9
|
20
|
14
|
19
|
|
Overall Study
COMPLETED
|
1
|
6
|
5
|
4
|
9
|
2
|
12
|
5
|
9
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
23
|
13
|
7
|
2
|
6
|
3
|
16
|
5
|
13
|
11
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=24 Participants
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=19 Participants
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=12 Participants
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=15 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=5 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=28 Participants
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=10 Participants
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=22 Participants
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=16 Participants
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=20 Participants
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
106 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
71 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
168 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 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
|
0 Participants
n=42 Participants
|
9 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
|
1 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
|
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
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
136 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
19 participants
n=7 Participants
|
12 participants
n=5 Participants
|
6 participants
n=4 Participants
|
15 participants
n=21 Participants
|
5 participants
n=8 Participants
|
28 participants
n=8 Participants
|
10 participants
n=24 Participants
|
22 participants
n=42 Participants
|
16 participants
n=42 Participants
|
20 participants
n=42 Participants
|
177 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 2.89 yearsPopulation: All participants who received any study drug.
Number of participants (pts) who experienced serious adverse events (SAE) and adverse events (AE).
Outcome measures
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=24 Participants
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=19 Participants
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=12 Participants
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=15 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=5 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=28 Participants
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=10 Participants
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=22 Participants
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=16 Participants
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=20 Participants
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any SAE
|
16 Participants
|
12 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
10 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events
Any AE
|
24 Participants
|
18 Participants
|
12 Participants
|
6 Participants
|
15 Participants
|
5 Participants
|
28 Participants
|
10 Participants
|
22 Participants
|
16 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Baseline to PD or Death due to Any Cause (Up to 1.54 years)Population: Part 2 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. Progressive Disease (PD) 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 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=10 Participants
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=13 Participants
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=4 Participants
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=26 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=9 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=20 Participants
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=14 Participants
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=19 Participants
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) (Part 2 Expansion)
|
0 percentage of participants
Interval 0.0 to 25.9
|
16.7 percentage of participants
Interval 0.9 to 58.2
|
7.7 percentage of participants
Interval 0.4 to 31.6
|
25.0 percentage of participants
Interval 1.3 to 75.1
|
30.8 percentage of participants
Interval 16.3 to 48.7
|
11.1 percentage of participants
Interval 0.6 to 42.9
|
20.0 percentage of participants
Interval 7.1 to 40.1
|
35.7 percentage of participants
Interval 15.3 to 61.0
|
5.3 percentage of participants
Interval 0.3 to 22.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to PD or Death due to Any Cause (Up to 0.92 years)Population: Part 1 mITT participants that were evaluable for this outcome measure.
Percentage of pts who achieved an objective response of Complete Response (CR) or Partial Response (PR). Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to \<10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. Modified RECIST (mRECIST) used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target les
Outcome measures
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=18 Participants
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=14 Participants
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) (Part 1 Escalation)
|
16.7 percentage of participants
Interval 4.7 to 37.7
|
21.4 percentage of participants
Interval 6.1 to 46.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from CR or PR to PD or Death due to Any Cause (Up to 1.54 years)Population: mITT participants that had CR or PR and were evaluable for this outcome measure.
Time from CR or PR to the earliest documented evidence of PD or death due to any cause. Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to \<10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
Outcome measures
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=3 Participants
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=3 Participants
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=1 Participants
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=1 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=1 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=8 Participants
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=1 Participants
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=4 Participants
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=5 Participants
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=1 Participants
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
11.1 months
The 90% Confidence Interval (CI) was not estimable due to insufficient number of events.
|
NA months
DOR median and 90% CI were not estimable due to insufficient number of events.
|
—
|
6.9 months
The 90% CI was not estimable due to insufficient number of events.
|
7.4 months
The 90% CI was not estimable due to insufficient number of events.
|
NA months
DOR median and 90% CI were not estimable due to insufficient number of events.
|
6.5 months
Interval 5.4 to
The 90% CI was not estimable due to insufficient number of events.
|
5.5 months
The 90% CI was not estimable due to insufficient number of events.
|
NA months
Interval 4.6 to
DOR median and 90% CI were not estimable due to insufficient number of events.
|
8.8 months
Interval 7.4 to
The 90% CI was not estimable due to insufficient number of events.
|
NA months
DOR median and 90% CI were not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: First Dose of Study Drug to PD (Up to 2.61 years)Population: mITT participants that were evaluable for this outcome measure.
Time from first dose of study drug to the earliest documented evidence of PD. Per RECIST v1.1, PD defined 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. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
Outcome measures
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=18 Participants
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=14 Participants
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=10 Participants
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=13 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=4 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=26 Participants
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=9 Participants
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=20 Participants
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=14 Participants
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=19 Participants
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP)
|
14.7 months
Interval 3.7 to
The 90% CI was not estimable due to insufficient number of events.
|
NA months
Interval 1.8 to
TTP median and 90% CI were not estimable due to insufficient number of events.
|
6.4 months
Interval 1.8 to
The 90% CI was not estimable due to insufficient number of events.
|
5.3 months
Interval 1.3 to 8.7
|
3.7 months
Interval 1.9 to 6.4
|
NA months
Interval 1.8 to
TTP median and 90% CI were not estimable due to insufficient number of events.
|
9.1 months
Interval 7.2 to 17.3
|
9.0 months
Interval 3.6 to
The 90% CI was not estimable due to insufficient number of events.
|
6.2 months
Interval 3.7 to
The 90% CI was not estimable due to insufficient number of events.
|
9.4 months
Interval 5.5 to 12.0
|
3.5 months
Interval 1.8 to 3.8
|
SECONDARY outcome
Timeframe: First Dose of Study Drug to PD or Death due to Any Cause (Up to 2.61 years)Population: mITT participants that were evaluable for this outcome measure.
Time from first dose of study drug to the earliest documented evidence of 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. PD 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. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
Outcome measures
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=18 Participants
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=14 Participants
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=10 Participants
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=13 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=4 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=26 Participants
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=9 Participants
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=20 Participants
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=14 Participants
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=19 Participants
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free-survival (PFS)
|
6.5 months
Interval 3.7 to 14.7
|
NA months
Interval 1.7 to
PFS median and 90% CI were not estimable due to insufficient number of events.
|
6.4 months
Interval 1.8 to
The 90% CI was not estimable due to insufficient number of events.
|
5.3 months
Interval 1.3 to 8.7
|
3.7 months
Interval 1.9 to 6.4
|
NA months
Interval 1.8 to
PFS median and 90% CI were not estimable due to insufficient number of events.
|
9.1 months
Interval 7.2 to 17.3
|
7.7 months
Interval 3.6 to
The 90% CI was not estimable due to insufficient number of events.
|
6.2 months
Interval 1.8 to
The 90% CI was not estimable due to insufficient number of events.
|
9.4 months
Interval 5.5 to 12.0
|
3.5 months
Interval 1.8 to 3.8
|
SECONDARY outcome
Timeframe: First Dose of Study Drug to Death due to Any Cause (Up to 2.82 years)Population: mITT participants that were evaluable for this outcome measure.
Time from first dose of study drug to date of death due to any cause. Participants who were still alive or who were lost to follow-up will be censored at the date of last contact.
Outcome measures
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=18 Participants
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=14 Participants
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=10 Participants
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=6 Participants
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=13 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=4 Participants
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=26 Participants
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=9 Participants
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=20 Participants
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=14 Participants
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=19 Participants
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 5.2 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
Interval 5.4 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
Interval 6.3 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
Interval 5.1 to
OS median and 90% CI were not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)Population: Part 1 participants who received any study drug and had evaluable Cmax data at each timepoint.
Measure the Cmax
Outcome measures
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=24 Participants
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=19 Participants
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Cycle 1 Day 1
|
77.4 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 67.7
|
132 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 76.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Cycle 1 Day 15
|
89.7 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 80.1
|
143 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 47.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)Population: Part 1 participants who received any study drug and had evaluable AUC data at each timepoint.
Measure the AUC 0-6 hours
Outcome measures
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=24 Participants
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel administered by IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=19 Participants
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration-time Curve (AUC) 0-6 Hours of Rebastinib (Part 1)
Cycle 1 Day 1
|
204 Hour times nanograms per hour (h*ng/mL)
Geometric Coefficient of Variation 67.9
|
337 Hour times nanograms per hour (h*ng/mL)
Geometric Coefficient of Variation 83.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK: Area Under the Concentration-time Curve (AUC) 0-6 Hours of Rebastinib (Part 1)
Cycle 1 Day 15
|
283 Hour times nanograms per hour (h*ng/mL)
Geometric Coefficient of Variation 80.8
|
457 Hour times nanograms per hour (h*ng/mL)
Geometric Coefficient of Variation 56.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Serious events: 16 serious events
Other events: 23 other events
Deaths: 7 deaths
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Serious events: 12 serious events
Other events: 15 other events
Deaths: 4 deaths
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Serious events: 2 serious events
Other events: 15 other events
Deaths: 1 deaths
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Serious events: 9 serious events
Other events: 28 other events
Deaths: 0 deaths
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Serious events: 5 serious events
Other events: 10 other events
Deaths: 2 deaths
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Serious events: 10 serious events
Other events: 22 other events
Deaths: 2 deaths
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
Serious events: 9 serious events
Other events: 16 other events
Deaths: 0 deaths
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
Serious events: 9 serious events
Other events: 20 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=24 participants at risk
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=19 participants at risk
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=12 participants at risk
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=6 participants at risk
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=15 participants at risk
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxelIV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=5 participants at risk
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=28 participants at risk
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=10 participants at risk
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=22 participants at risk
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=16 participants at risk
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=20 participants at risk
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Angina unstable
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Cardiac arrest
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Pericardial effusion
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Retinal vein occlusion
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 5 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Asthenia
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Death
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Fatigue
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Gait disturbance
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Incarcerated hernia
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Oedema peripheral
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
General disorders
Pyrexia
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
COVID-19
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Clostridium difficile colitis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Peritonsillitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Pneumonia
|
12.5%
3/24 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Pyelonephritis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Sepsis
|
12.5%
3/24 • Number of events 3 • Baseline up to 2.89 years
|
15.8%
3/19 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Infections and infestations
Septic shock
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 3 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
4.2%
1/24 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Dysarthria
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Noninfective encephalitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Syncope
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Vascular disorders
Embolism
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
Other adverse events
| Measure |
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=24 participants at risk
Dose escalation of rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=19 participants at risk
Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=12 participants at risk
Dose expansion in TNBC. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=6 participants at risk
Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=15 participants at risk
Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxelIV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=5 participants at risk
Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=28 participants at risk
Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=10 participants at risk
Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=22 participants at risk
Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2
n=16 participants at risk
Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2
n=20 participants at risk
Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Axillary pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Catheter site haematoma
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Chest discomfort
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Chest pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 2 • Baseline up to 2.89 years
|
|
General disorders
Chills
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Fatigue
|
37.5%
9/24 • Number of events 12 • Baseline up to 2.89 years
|
31.6%
6/19 • Number of events 10 • Baseline up to 2.89 years
|
58.3%
7/12 • Number of events 9 • Baseline up to 2.89 years
|
66.7%
4/6 • Number of events 7 • Baseline up to 2.89 years
|
60.0%
9/15 • Number of events 10 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 4 • Baseline up to 2.89 years
|
60.7%
17/28 • Number of events 21 • Baseline up to 2.89 years
|
50.0%
5/10 • Number of events 9 • Baseline up to 2.89 years
|
54.5%
12/22 • Number of events 21 • Baseline up to 2.89 years
|
43.8%
7/16 • Number of events 10 • Baseline up to 2.89 years
|
35.0%
7/20 • Number of events 13 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
2/24 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 2 • Baseline up to 2.89 years
|
15.0%
3/20 • Number of events 3 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/24 • Baseline up to 2.89 years
|
10.5%
2/19 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 2 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Blood and lymphatic system disorders
Anaemia
|
20.8%
5/24 • Number of events 6 • Baseline up to 2.89 years
|
26.3%
5/19 • Number of events 11 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 3 • Baseline up to 2.89 years
|
50.0%
3/6 • Number of events 3 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 3 • Baseline up to 2.89 years
|
17.9%
5/28 • Number of events 13 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 9 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
31.2%
5/16 • Number of events 6 • Baseline up to 2.89 years
|
40.0%
8/20 • Number of events 28 • Baseline up to 2.89 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.2%
1/24 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 7 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 7 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 4 • Baseline up to 2.89 years
|
|
Cardiac disorders
Atrial fibrillation
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Pericardial effusion
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Ear and labyrinth disorders
Ear pain
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Cataract
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Dry eye
|
12.5%
3/24 • Number of events 3 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
20.0%
3/15 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
14.3%
4/28 • Number of events 4 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 2 • Baseline up to 2.89 years
|
13.6%
3/22 • Number of events 3 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Eye pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Eyelid cyst
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Glaucoma
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
25.0%
3/12 • Number of events 3 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
30.0%
3/10 • Number of events 5 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Macular hole
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Eye disorders
Night blindness
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
20.0%
3/15 • Number of events 3 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Papilloedema
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Photopsia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Eye disorders
Vision blurred
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
21.1%
4/19 • Number of events 7 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 3 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 2 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 5 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 3 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Abdominal distension
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
14.3%
4/28 • Number of events 6 • Baseline up to 2.89 years
|
30.0%
3/10 • Number of events 3 • Baseline up to 2.89 years
|
13.6%
3/22 • Number of events 4 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 2 • Baseline up to 2.89 years
|
25.0%
5/20 • Number of events 5 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
35.7%
10/28 • Number of events 15 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 3 • Baseline up to 2.89 years
|
13.6%
3/22 • Number of events 3 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 3 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Anal incontinence
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 16 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Constipation
|
12.5%
3/24 • Number of events 4 • Baseline up to 2.89 years
|
31.6%
6/19 • Number of events 6 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 2 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.89 years
|
33.3%
5/15 • Number of events 12 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 2 • Baseline up to 2.89 years
|
39.3%
11/28 • Number of events 15 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 2 • Baseline up to 2.89 years
|
31.8%
7/22 • Number of events 10 • Baseline up to 2.89 years
|
56.2%
9/16 • Number of events 13 • Baseline up to 2.89 years
|
40.0%
8/20 • Number of events 10 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
3/24 • Number of events 3 • Baseline up to 2.89 years
|
36.8%
7/19 • Number of events 8 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 3 • Baseline up to 2.89 years
|
46.7%
7/15 • Number of events 9 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 2 • Baseline up to 2.89 years
|
21.4%
6/28 • Number of events 10 • Baseline up to 2.89 years
|
60.0%
6/10 • Number of events 6 • Baseline up to 2.89 years
|
22.7%
5/22 • Number of events 12 • Baseline up to 2.89 years
|
31.2%
5/16 • Number of events 8 • Baseline up to 2.89 years
|
40.0%
8/20 • Number of events 13 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
6/24 • Number of events 6 • Baseline up to 2.89 years
|
15.8%
3/19 • Number of events 3 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.89 years
|
20.0%
3/15 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
35.7%
10/28 • Number of events 11 • Baseline up to 2.89 years
|
40.0%
4/10 • Number of events 4 • Baseline up to 2.89 years
|
18.2%
4/22 • Number of events 4 • Baseline up to 2.89 years
|
31.2%
5/16 • Number of events 5 • Baseline up to 2.89 years
|
25.0%
5/20 • Number of events 5 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
33.3%
5/15 • Number of events 6 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
3/24 • Number of events 4 • Baseline up to 2.89 years
|
15.8%
3/19 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 3 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
27.3%
6/22 • Number of events 8 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Hyperaesthesia teeth
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Internal hernia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Nausea
|
29.2%
7/24 • Number of events 8 • Baseline up to 2.89 years
|
15.8%
3/19 • Number of events 3 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 3 • Baseline up to 2.89 years
|
50.0%
3/6 • Number of events 3 • Baseline up to 2.89 years
|
46.7%
7/15 • Number of events 12 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
39.3%
11/28 • Number of events 17 • Baseline up to 2.89 years
|
40.0%
4/10 • Number of events 4 • Baseline up to 2.89 years
|
50.0%
11/22 • Number of events 12 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 9 • Baseline up to 2.89 years
|
40.0%
8/20 • Number of events 8 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Rectal discharge
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 3 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Stomatitis
|
20.8%
5/24 • Number of events 5 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
20.0%
3/15 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
21.4%
6/28 • Number of events 8 • Baseline up to 2.89 years
|
40.0%
4/10 • Number of events 4 • Baseline up to 2.89 years
|
13.6%
3/22 • Number of events 3 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 5 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Tongue blistering
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
4/24 • Number of events 4 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 3 • Baseline up to 2.89 years
|
60.0%
3/5 • Number of events 3 • Baseline up to 2.89 years
|
17.9%
5/28 • Number of events 7 • Baseline up to 2.89 years
|
30.0%
3/10 • Number of events 4 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
37.5%
6/16 • Number of events 14 • Baseline up to 2.89 years
|
30.0%
6/20 • Number of events 6 • Baseline up to 2.89 years
|
|
General disorders
Asthenia
|
12.5%
3/24 • Number of events 4 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Feeling jittery
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Gait disturbance
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Generalised oedema
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Implant site pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Influenza like illness
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Localised oedema
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 6 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
General disorders
Malaise
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Non-cardiac chest pain
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Oedema peripheral
|
20.8%
5/24 • Number of events 5 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
25.0%
3/12 • Number of events 3 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
60.0%
3/5 • Number of events 3 • Baseline up to 2.89 years
|
46.4%
13/28 • Number of events 27 • Baseline up to 2.89 years
|
40.0%
4/10 • Number of events 7 • Baseline up to 2.89 years
|
45.5%
10/22 • Number of events 13 • Baseline up to 2.89 years
|
43.8%
7/16 • Number of events 12 • Baseline up to 2.89 years
|
35.0%
7/20 • Number of events 8 • Baseline up to 2.89 years
|
|
General disorders
Pain
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Peripheral swelling
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 3 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
General disorders
Pyrexia
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 3 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 4 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
13.6%
3/22 • Number of events 4 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
15.0%
3/20 • Number of events 3 • Baseline up to 2.89 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 5 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Immune system disorders
Food allergy
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Abscess oral
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Acute sinusitis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Bronchitis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
COVID-19
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Candida infection
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Cellulitis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 3 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Infections and infestations
Cystitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Infections and infestations
Eye infection
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Fungal infection
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Hordeolum
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Infection
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Infections and infestations
Laryngitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Nail infection
|
4.2%
1/24 • Number of events 3 • Baseline up to 2.89 years
|
10.5%
2/19 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Infections and infestations
Onychomycosis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Oral candidiasis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 3 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 4 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Oral herpes
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Paronychia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Parotitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Pneumonia
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
10.5%
2/19 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 2 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
10.5%
2/19 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 4 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Infections and infestations
Skin infection
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 4 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Urinary tract infection
|
16.7%
4/24 • Number of events 4 • Baseline up to 2.89 years
|
21.1%
4/19 • Number of events 6 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 2 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 3 • Baseline up to 2.89 years
|
14.3%
4/28 • Number of events 8 • Baseline up to 2.89 years
|
40.0%
4/10 • Number of events 4 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 3 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Urosepsis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
2/24 • Number of events 3 • Baseline up to 2.89 years
|
10.5%
2/19 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
21.4%
6/28 • Number of events 10 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Incision site rash
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Alanine aminotransferase increased
|
20.8%
5/24 • Number of events 5 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 2 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
15.0%
3/20 • Number of events 4 • Baseline up to 2.89 years
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 2 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
18.2%
4/22 • Number of events 4 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 3 • Baseline up to 2.89 years
|
|
Investigations
Blood albumin decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Blood alkaline phosphatase increased
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
26.7%
4/15 • Number of events 4 • Baseline up to 2.89 years
|
60.0%
3/5 • Number of events 4 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Blood chloride decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Blood creatine increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Investigations
Blood creatinine increased
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 3 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Blood urea increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Carbon dioxide increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Ejection fraction decreased
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Haematocrit decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Heart rate increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
International normalised ratio increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 3 • Baseline up to 2.89 years
|
|
Investigations
Intraocular pressure increased
|
12.5%
3/24 • Number of events 3 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
14.3%
4/28 • Number of events 5 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 2 • Baseline up to 2.89 years
|
27.3%
6/22 • Number of events 6 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 3 • Baseline up to 2.89 years
|
25.0%
5/20 • Number of events 8 • Baseline up to 2.89 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 5 • Baseline up to 2.89 years
|
|
Investigations
Monocyte count increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Neutrophil count decreased
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 5 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 4 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
4/20 • Number of events 9 • Baseline up to 2.89 years
|
|
Investigations
Neutrophil count increased
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Protein total decreased
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 4 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 4 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Urine output decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Investigations
Weight decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 5 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 3 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
Weight increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 10 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 4 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 7 • Baseline up to 2.89 years
|
|
Investigations
White blood cell count decreased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 2 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 4 • Baseline up to 2.89 years
|
|
Investigations
White blood cell count increased
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Investigations
White blood cells urine positive
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.8%
5/24 • Number of events 5 • Baseline up to 2.89 years
|
10.5%
2/19 • Number of events 2 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
14.3%
4/28 • Number of events 5 • Baseline up to 2.89 years
|
30.0%
3/10 • Number of events 3 • Baseline up to 2.89 years
|
18.2%
4/22 • Number of events 5 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 3 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
2/24 • Number of events 3 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 4 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 5 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 2 • Baseline up to 2.89 years
|
18.2%
4/22 • Number of events 4 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 5 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
3/24 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
26.7%
4/15 • Number of events 4 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 3 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
12.5%
3/24 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
2/24 • Number of events 3 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
4/24 • Number of events 5 • Baseline up to 2.89 years
|
10.5%
2/19 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
26.7%
4/15 • Number of events 5 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
17.9%
5/28 • Number of events 12 • Baseline up to 2.89 years
|
30.0%
3/10 • Number of events 4 • Baseline up to 2.89 years
|
27.3%
6/22 • Number of events 8 • Baseline up to 2.89 years
|
31.2%
5/16 • Number of events 6 • Baseline up to 2.89 years
|
15.0%
3/20 • Number of events 6 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
3/24 • Number of events 3 • Baseline up to 2.89 years
|
15.8%
3/19 • Number of events 6 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
28.6%
8/28 • Number of events 12 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 2 • Baseline up to 2.89 years
|
18.2%
4/22 • Number of events 7 • Baseline up to 2.89 years
|
37.5%
6/16 • Number of events 9 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
2/24 • Number of events 3 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 4 • Baseline up to 2.89 years
|
15.0%
3/20 • Number of events 4 • Baseline up to 2.89 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
10.5%
2/19 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 3 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Number of events 6 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
26.7%
4/15 • Number of events 4 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
25.0%
7/28 • Number of events 7 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
37.5%
6/16 • Number of events 6 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
21.4%
6/28 • Number of events 11 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 2 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 2 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 2 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 3 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.2%
1/24 • Number of events 8 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
60.0%
3/5 • Number of events 4 • Baseline up to 2.89 years
|
25.0%
7/28 • Number of events 10 • Baseline up to 2.89 years
|
40.0%
4/10 • Number of events 5 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
37.5%
6/16 • Number of events 10 • Baseline up to 2.89 years
|
25.0%
5/20 • Number of events 7 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
2/24 • Number of events 6 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 2 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
20.0%
3/15 • Number of events 3 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 2 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 5 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
25.0%
4/16 • Number of events 4 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
21.4%
6/28 • Number of events 8 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Dizziness
|
20.8%
5/24 • Number of events 6 • Baseline up to 2.89 years
|
21.1%
4/19 • Number of events 6 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
17.9%
5/28 • Number of events 5 • Baseline up to 2.89 years
|
30.0%
3/10 • Number of events 3 • Baseline up to 2.89 years
|
13.6%
3/22 • Number of events 3 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/24 • Baseline up to 2.89 years
|
10.5%
2/19 • Number of events 2 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 3 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
31.2%
5/16 • Number of events 5 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 3 • Baseline up to 2.89 years
|
15.8%
3/19 • Number of events 3 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
14.3%
4/28 • Number of events 4 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 2 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Nervous system disorders
Memory impairment
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Nervous system disorders
Neuropathy peripheral
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 3 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Nervous system disorders
Paraesthesia
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.8%
5/24 • Number of events 6 • Baseline up to 2.89 years
|
31.6%
6/19 • Number of events 7 • Baseline up to 2.89 years
|
25.0%
3/12 • Number of events 3 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 5 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 4 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
46.4%
13/28 • Number of events 25 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 2 • Baseline up to 2.89 years
|
50.0%
11/22 • Number of events 18 • Baseline up to 2.89 years
|
25.0%
4/16 • Number of events 5 • Baseline up to 2.89 years
|
20.0%
4/20 • Number of events 10 • Baseline up to 2.89 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Sciatica
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Nervous system disorders
Taste disorder
|
12.5%
3/24 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Psychiatric disorders
Anxiety
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Psychiatric disorders
Depression
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 4 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Psychiatric disorders
Insomnia
|
12.5%
3/24 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
3/15 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 5 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 2 • Baseline up to 2.89 years
|
18.2%
4/22 • Number of events 4 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 3 • Baseline up to 2.89 years
|
15.0%
3/20 • Number of events 3 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Hydronephrosis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Renal failure
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Urinary hesitation
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Urinary incontinence
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Renal and urinary disorders
Urinary retention
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 4 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
4/24 • Number of events 5 • Baseline up to 2.89 years
|
10.5%
2/19 • Number of events 2 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 3 • Baseline up to 2.89 years
|
17.9%
5/28 • Number of events 6 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 3 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 4 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
4/24 • Number of events 7 • Baseline up to 2.89 years
|
26.3%
5/19 • Number of events 8 • Baseline up to 2.89 years
|
25.0%
3/12 • Number of events 5 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
25.0%
7/28 • Number of events 10 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 2 • Baseline up to 2.89 years
|
40.9%
9/22 • Number of events 12 • Baseline up to 2.89 years
|
18.8%
3/16 • Number of events 4 • Baseline up to 2.89 years
|
15.0%
3/20 • Number of events 7 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 2 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 3 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 2 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hyposecretion
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
4/24 • Number of events 4 • Baseline up to 2.89 years
|
21.1%
4/19 • Number of events 6 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 2 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 3 • Baseline up to 2.89 years
|
33.3%
5/15 • Number of events 5 • Baseline up to 2.89 years
|
40.0%
2/5 • Number of events 3 • Baseline up to 2.89 years
|
50.0%
14/28 • Number of events 18 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 2 • Baseline up to 2.89 years
|
22.7%
5/22 • Number of events 5 • Baseline up to 2.89 years
|
37.5%
6/16 • Number of events 7 • Baseline up to 2.89 years
|
30.0%
6/20 • Number of events 7 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Blister
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Nail bed tenderness
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/24 • Baseline up to 2.89 years
|
15.8%
3/19 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
17.9%
5/28 • Number of events 7 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
17.9%
5/28 • Number of events 5 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
12.5%
3/24 • Number of events 4 • Baseline up to 2.89 years
|
15.8%
3/19 • Number of events 4 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 2 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
10.7%
3/28 • Number of events 3 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
2/24 • Number of events 2 • Baseline up to 2.89 years
|
15.8%
3/19 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/24 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 8 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
9.1%
2/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
10.0%
2/20 • Number of events 2 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
16.7%
1/6 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Vascular disorders
Embolism
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Vascular disorders
Flushing
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
25.0%
3/12 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
10.0%
1/10 • Number of events 1 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Vascular disorders
Hot flush
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
6.7%
1/15 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
7.1%
2/28 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
13.6%
3/22 • Number of events 3 • Baseline up to 2.89 years
|
6.2%
1/16 • Number of events 1 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
16.7%
2/12 • Number of events 2 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
33.3%
5/15 • Number of events 5 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
35.7%
10/28 • Number of events 20 • Baseline up to 2.89 years
|
30.0%
3/10 • Number of events 3 • Baseline up to 2.89 years
|
13.6%
3/22 • Number of events 3 • Baseline up to 2.89 years
|
25.0%
4/16 • Number of events 7 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • Number of events 1 • Baseline up to 2.89 years
|
5.3%
1/19 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
20.0%
2/10 • Number of events 3 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
12.5%
2/16 • Number of events 2 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
33.3%
2/6 • Number of events 3 • Baseline up to 2.89 years
|
13.3%
2/15 • Number of events 4 • Baseline up to 2.89 years
|
20.0%
1/5 • Number of events 1 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
4.5%
1/22 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
8.3%
1/12 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
3.6%
1/28 • Number of events 1 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
0.00%
0/20 • Baseline up to 2.89 years
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/24 • Baseline up to 2.89 years
|
0.00%
0/19 • Baseline up to 2.89 years
|
0.00%
0/12 • Baseline up to 2.89 years
|
0.00%
0/6 • Baseline up to 2.89 years
|
0.00%
0/15 • Baseline up to 2.89 years
|
0.00%
0/5 • Baseline up to 2.89 years
|
0.00%
0/28 • Baseline up to 2.89 years
|
0.00%
0/10 • Baseline up to 2.89 years
|
0.00%
0/22 • Baseline up to 2.89 years
|
0.00%
0/16 • Baseline up to 2.89 years
|
5.0%
1/20 • Number of events 1 • Baseline up to 2.89 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place