Trial Outcomes & Findings for Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS) (NCT NCT02103478)
NCT ID: NCT02103478
Last Updated: 2024-08-27
Results Overview
Mean AUC0-t of oral decitabine given with cedazuridine (E7727) following IV decitabine 20 mg/m\^2 infusion on Day 5. AUCs were calculated by the linear up/log down method using the measured concentration-time values above the BQL (below the limit of quantification).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Day 5
Results posted on
2024-08-27
Participant Flow
In Phase 1, 127 participants were screened and 44 were randomized and received at least one treatment. In Phase 2, a total of 138 were screened, 86 were randomized, and 80 received at least one treatment.
Response data for Phase 1 per June 2017 data cut and for Phase 2 per June 2018 data cut. Median follow up in Phase 1 was 1915.5 days (range: 1771-2213) and 1563.0 days in Phase 2 (range: 1199-1710).
Participant milestones
| Measure |
Phase 1 Dose Escalation Cohort 1
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation Sequence A
Participants were randomized in a 1:1 ratio to receive oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) in Sequence A. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Dose Confirmation Sequence B
Participants were randomized in a 1:1 ratio to receive IV decibatine (20 mg/m\^2) Dailyx5 in Course 1 followed by oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 2 (28 days per course) in Sequence B. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination Sequence A
Participants were randomized in a 1:1 ratio to receive oral cedazuridine (100 mg) + decitabine (35 mg) tablets Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) in Sequence A. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination Sequence B
Participants were randomized in a 1:1 ratio to receive IV decibatine (20 mg/m\^2) Dailyx5 in Course 1 followed by oral cedazuridine (100 mg) + decitabine (35 mg) tablets Dailyx5 in Course 2 (28 days per course) in Sequence B. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
6
|
6
|
19
|
25
|
25
|
16
|
14
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
6
|
6
|
19
|
25
|
25
|
16
|
14
|
Reasons for withdrawal
| Measure |
Phase 1 Dose Escalation Cohort 1
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation Sequence A
Participants were randomized in a 1:1 ratio to receive oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) in Sequence A. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Dose Confirmation Sequence B
Participants were randomized in a 1:1 ratio to receive IV decibatine (20 mg/m\^2) Dailyx5 in Course 1 followed by oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 2 (28 days per course) in Sequence B. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination Sequence A
Participants were randomized in a 1:1 ratio to receive oral cedazuridine (100 mg) + decitabine (35 mg) tablets Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) in Sequence A. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination Sequence B
Participants were randomized in a 1:1 ratio to receive IV decibatine (20 mg/m\^2) Dailyx5 in Course 1 followed by oral cedazuridine (100 mg) + decitabine (35 mg) tablets Dailyx5 in Course 2 (28 days per course) in Sequence B. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
2
|
2
|
1
|
1
|
5
|
15
|
14
|
10
|
11
|
|
Overall Study
Progressive Disease
|
2
|
1
|
2
|
0
|
9
|
1
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
4
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
1
|
3
|
2
|
0
|
3
|
8
|
8
|
4
|
2
|
Baseline Characteristics
Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)
Baseline characteristics by cohort
| Measure |
Phase 1 Dose Escalation Cohort 1
n=7 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=50 Participants
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=30 Participants
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
72 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
74 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
75.2 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
71.6 years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
69.7 years
STANDARD_DEVIATION 10.72 • n=8 Participants
|
69.6 years
STANDARD_DEVIATION 10.57 • n=8 Participants
|
70.6 years
STANDARD_DEVIATION 9.67 • n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
33 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
91 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
113 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
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
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
114 Participants
n=24 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
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
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
16 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
19 participants
n=21 Participants
|
42 participants
n=8 Participants
|
22 participants
n=8 Participants
|
108 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 5Population: Participants who were successfully dosed according to criteria for both ASTX727 and IV decitabine dosing and with evaluable pharmacokinetic (PK) measurements are included.
Mean AUC0-t of oral decitabine given with cedazuridine (E7727) following IV decitabine 20 mg/m\^2 infusion on Day 5. AUCs were calculated by the linear up/log down method using the measured concentration-time values above the BQL (below the limit of quantification).
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=5 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Mean Decitabine Area Under the Concentration Versus Time Curve (AUC0-t) on Day 5 by Cohort in Phase 1
|
53.6 ng*h/mL
Geometric Coefficient of Variation 40
|
68.9 ng*h/mL
Geometric Coefficient of Variation 44
|
94.8 ng*h/mL
Geometric Coefficient of Variation 46
|
221 ng*h/mL
Geometric Coefficient of Variation 74
|
146 ng*h/mL
Geometric Coefficient of Variation 50
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose to Day 5Population: Participants with evaluable PK measurements are included. Phase 2 crossover design was used to compare AUC ratio for oral and IV administration.
Decitabine 5-day AUC ratio following IV decitabine 20 mg/m\^2 infusion versus concomitant oral administration of decitabine + cedazuridine (E7727) or ASTX727 in the dose combination and fixed-dose combination stages, respectively. AUC0-t (the area under the concentration-time curve from time zero to the time of the last (tlast) quantifiable concentration (Ct)) by dose/cohort and course/days was used for estimating decitabine cumulative 5-day AUC0-t exposures.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=40 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=24 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Mean Decitabine Area Under the Plasma Concentration Versus Time Curve Ratio (5-day AUC0-t) in Phase 2
|
93.52 Ratio of Geometric LSM
Interval 82.1 to 106.5
|
97.59 Ratio of Geometric LSM
Interval 80.48 to 118.3
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28 in Course 1 (28 days per course)Population: The safety population includes participants in Phase 1 who received at least one dose of study drug.
Number of participants with protocol-specified dose-limiting toxicities (DLTs) in the dose escalation stage. DLTs were defined using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAEv4.0), specifically ≥ Grade 3 non-hematologic toxicity (except Grade 3 nausea, vomiting, or diarrhea that is controllable by anti-emetics or optimal therapy or related to underlying disease or disease progression), specific Grade 3 laboratory tests, related prolonged Grade 4 thrombocytopenia or neutropenia that was not present prior to dosing, does not resolve within 14 days, and is not related to underlying disease, or any toxicity related to study treatment that results in treatment delays of \>4 weeks after Day 28.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=7 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicity in Phase 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose to Day 28 in Course 2 (28 days per course)Population: The pharmacodynamic population includes all participants with evaluable data who received at least one dose of investigational product.
Mean maximum % long interspread nuclear element-1 (LINE-1) demethylation after oral decitabine + cedazuridine (E7727) or ASTX727 (Course 1 or Course 2 - Treatment) compared with IV decitabine 20 mg/m\^2 (Course 1 or Course 2 - IV Decitabine) in the dose confirmation and fixed-dose combination stages, respectively. Least squares mean of maximum %LINE-1 methylation change from baseline.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=48 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=30 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Mean Maximum %LINE Demethylation in Phase 2
Course 1 - Treatment
|
11.159 Percent
Interval 9.023 to 13.294
|
10.077 Percent
Interval 7.696 to 12.459
|
—
|
—
|
—
|
—
|
—
|
|
Mean Maximum %LINE Demethylation in Phase 2
Course 1 - IV Decitabine
|
11.303 Percent
Interval 9.167 to 13.439
|
12.665 Percent
Interval 10.12 to 15.211
|
—
|
—
|
—
|
—
|
—
|
|
Mean Maximum %LINE Demethylation in Phase 2
Course 2 - Treatment
|
9.833 Percent
Interval 7.446 to 12.219
|
8.134 Percent
Interval 4.438 to 11.83
|
—
|
—
|
—
|
—
|
—
|
|
Mean Maximum %LINE Demethylation in Phase 2
Course 2 - IV Decitabine
|
9.920 Percent
Interval 7.534 to 12.307
|
8.230 Percent
Interval 4.887 to 11.574
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 29 monthsPopulation: The efficacy population includes all participants in Phase 2 who received at least one dose of investigational product.
The evaluation of response was based on International Working Group (IWG) 2006 MDS Response Criteria, with overall response calculated as number of participants with complete response+partial response+marrow complete response+hematological improvement (CR+PR+mCR+HI).
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=50 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=30 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Overall Response in Phase 2
|
29 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At specified timepoints from 0 to 24 hours post-dosePopulation: Participants with evaluable PK measurements are included.
AUC is a measure of the plasma concentration of the drug over time (AUC0-8). PK parameters are reported for the dose escalation stage by cohort in Phase 1 and dose confirmation and fixed-dose combination stages in Phase 2.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=6 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=37 Participants
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=19 Participants
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve of Cedazuridine (E7727) and Cedazuridine-epimer
Cedazuridine
|
1650 ng*h/mL
Geometric Coefficient of Variation 43
|
1990 ng*h/mL
Geometric Coefficient of Variation 64
|
3190 ng*h/mL
Geometric Coefficient of Variation 53
|
4830 ng*h/mL
Geometric Coefficient of Variation 51
|
3490 ng*h/mL
Geometric Coefficient of Variation 46
|
2370 ng*h/mL
Geometric Coefficient of Variation 56.8
|
1510 ng*h/mL
Geometric Coefficient of Variation 49.4
|
|
Area Under the Concentration Versus Time Curve of Cedazuridine (E7727) and Cedazuridine-epimer
Cedazuridine-epimer
|
503 ng*h/mL
Geometric Coefficient of Variation 20
|
917 ng*h/mL
Geometric Coefficient of Variation 64
|
1670 ng*h/mL
Geometric Coefficient of Variation 48
|
2180 ng*h/mL
Geometric Coefficient of Variation 34
|
1560 ng*h/mL
Geometric Coefficient of Variation 56
|
1190 ng*h/mL
Geometric Coefficient of Variation 48.3
|
710 ng*h/mL
Geometric Coefficient of Variation 38
|
SECONDARY outcome
Timeframe: At specific timepoints from 0 to 24 hours post-dosePopulation: Participants with evaluable PK measurements are included.
Cmax is the maximum observed plasma concentration. PK parameters are reported for the dose escalation stage by cohort in Phase 1 and dose confirmation and fixed-dose combination stages in Phase 2.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=6 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=47 Participants
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=29 Participants
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Cedazuridine (E7727) and Cedazuridine-epimer
Cedazuridine
|
309 ng/mL
Geometric Coefficient of Variation 50
|
376 ng/mL
Geometric Coefficient of Variation 67
|
636 ng/mL
Geometric Coefficient of Variation 50
|
697 ng/mL
Geometric Coefficient of Variation 75
|
570 ng/mL
Geometric Coefficient of Variation 51
|
451 ng/mL
Geometric Coefficient of Variation 51.4
|
293 ng/mL
Geometric Coefficient of Variation 43.1
|
|
Maximum Observed Plasma Concentration (Cmax) of Cedazuridine (E7727) and Cedazuridine-epimer
Cedazuridine-epimer
|
96 ng/mL
Geometric Coefficient of Variation 22
|
184 ng/mL
Geometric Coefficient of Variation 70
|
343 ng/mL
Geometric Coefficient of Variation 44
|
321 ng/mL
Geometric Coefficient of Variation 47
|
291 ng/mL
Geometric Coefficient of Variation 54
|
235 ng/mL
Geometric Coefficient of Variation 49
|
154 ng/mL
Geometric Coefficient of Variation 44.6
|
SECONDARY outcome
Timeframe: At specific timepoints from 0 to 24 hours post-dosePopulation: Participants with evaluable PK measurements are included.
Tmax is the time to maximum observed plasma concentration. PK parameters are reported for the dose escalation stage by cohort in Phase 1 and the dose confirmation and fixed-dose combination stages in Phase 2.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=6 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=47 Participants
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=30 Participants
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Cedazuridine (E7727) and Cedazuridine-epimer
Cedazuridine
|
3 hours
Interval 2.0 to 4.0
|
3 hours
Interval 2.0 to 4.0
|
3 hours
Interval 3.0 to 4.0
|
3 hours
Interval 2.0 to 6.0
|
3 hours
Interval 2.0 to 6.0
|
3 hours
Interval 1.5 to 4.08
|
3 hours
Interval 2.0 to 7.18
|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Cedazuridine (E7727) and Cedazuridine-epimer
Cedazuridine-epimer
|
3 hours
Interval 2.0 to 4.0
|
3 hours
Interval 2.0 to 3.0
|
3 hours
Interval 3.0 to 4.0
|
3 hours
Interval 2.0 to 6.0
|
3 hours
Interval 2.0 to 6.0
|
3 hours
Interval 1.5 to 6.17
|
3.05 hours
Interval 2.0 to 7.2
|
SECONDARY outcome
Timeframe: At specific timepoints from 0 to 24 hours post-dosePopulation: Participants with evaluable PK measurements are included.
Cmax is the maximum observed plasma concentration. PK parameters for plasma decitabine are reported for the dose escalation stage by cohort in Phase 1 and dose confirmation and fixed-dose combination stages in Phase 2.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=6 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=47 Participants
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=29 Participants
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Decitabine
|
54.0 ng/mL
Geometric Coefficient of Variation 36
|
76.5 ng/mL
Geometric Coefficient of Variation 42
|
80.9 ng/mL
Geometric Coefficient of Variation 41
|
161 ng/mL
Geometric Coefficient of Variation 51
|
138 ng/mL
Geometric Coefficient of Variation 55
|
126 ng/mL
Geometric Coefficient of Variation 70.9
|
126 ng/mL
Geometric Coefficient of Variation 76.2
|
SECONDARY outcome
Timeframe: At specific timepoints from 0 to 24 hours post-dosePopulation: Participants with evaluable PK measurements are included.
Tmax is the time to reach maximum plasma concentration for decitabine. PK parameters for plasma decitabine are reported for the dose confirmation and fixed-dose combination stages.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=49 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=29 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of Decitabine in Phase 2
|
1.00 hours
Interval 0.47 to 3.0
|
0.95 hours
Interval 0.47 to 2.12
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 32 MonthsPopulation: The efficacy population includes all participants in Phase 1 who received at least one dose of investigational product.
Duration of response (in number of days) was calculated from the first time the response was observed to time of relapse or last time point in the study.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=7 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Duration of Complete Response in Phase 1
|
546.00 days
Interval 546.0 to 546.0
|
364.00 days
Interval 56.0 to 672.0
|
470.00 days
Interval 470.0 to 470.0
|
29.00 days
Interval 29.0 to 29.0
|
399.0 days
Interval 202.0 to 420.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 29 monthsPopulation: The efficacy population includes all participants in Phase 2 who received at least one dose of investigational product.
Duration of response (in number of days) was calculated from the first time the response was observed to time of relapse or last time point in the study. Kaplan-Meier estimate for complete response is shown.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=50 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=30 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Duration of Complete Response in Phase 2 - Kaplan-Meier Estimate
|
413.0 days
Interval 180.0 to 553.0
|
155.0 days
Interval 35.0 to 285.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose to Day 28 in Course 2 (28 days per course)Population: The pharmacodynamic population includes all participants in Phase 1 with evaluable data who received at least one dose of investigational product.
Mean maximum % long interspread nuclear element-1 (LINE-1) demethylation decrease from baseline after oral decitabine + cedazuridine (E7727) or ASTX727 compared with IV decitabine 20 mg/m\^2 in the dose escalation stage.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=6 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=18 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Mean Maximum %LINE Demethylation in Phase 1
Course 1
|
-8.3 Percent change
Standard Deviation 5.28
|
-9.2 Percent change
Standard Deviation 5.84
|
-10.5 Percent change
Standard Deviation 7.55
|
-12.1 Percent change
Standard Deviation 7.82
|
-11.7 Percent change
Standard Deviation 5.67
|
—
|
—
|
|
Mean Maximum %LINE Demethylation in Phase 1
Course 2
|
-8.0 Percent change
Standard Deviation 3.56
|
-7.1 Percent change
Standard Deviation 2.92
|
-8.9 Percent change
Standard Deviation 5.42
|
-8.6 Percent change
Standard Deviation 3.24
|
-7.5 Percent change
Standard Deviation 5.47
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 32 monthsPopulation: The efficacy population includes all participants in Phase 1 who received at least one dose of investigational product.
The evaluation of response was based on International Working Group 2006 MDS Response Criteria, with overall response calculated as number of participants with complete response+partial response+marrow complete response+hematological improvement (CR+PR+mCR+HI).
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=7 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Overall Response in Phase 1
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The safety population includes all participants in Phase 1 and Phase 2 who received at least one dose of investigational product.
Number of participants with any treatment-emergent adverse event (AE) and any AE graded ≥3 using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=7 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=50 Participants
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=30 Participants
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Any Adverse Event
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
19 Participants
|
50 Participants
|
30 Participants
|
|
Number of Participants With Adverse Events
Any Grade ≥3 Adverse Event
|
5 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
18 Participants
|
48 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to 32 monthsPopulation: The efficacy population includes all participants in Phase 1 and Phase 2 who received at least one dose of investigational product.
Hematological improvement was calculated as defined by the IWG 2006 MDS Response Criteria.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=7 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=50 Participants
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=30 Participants
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematological Improvement
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 32 monthsPopulation: The efficacy population includes all participants in Phase 1 and Phase 2 who received at least one dose of investigational product and were transfusion-dependent at baseline. Number analyzed is the number of participants who were transfusion-dependent at baseline.
Transfusion independence was calculated based on the number of transfusion-dependent participants at baseline who had no red blood cell or platelet transfusions for 56 consecutive days or more after treatment.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=4 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=2 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=5 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=12 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=29 Participants
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=21 Participants
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Transfusion Independence
Red Blood Cell
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
11 Participants
|
8 Participants
|
|
Number of Participants With Transfusion Independence
Platelet
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 32 monthsPopulation: The efficacy population includes all participants in Phase 1 and Phase 2 who received at least one dose of investigational product.
Number of participants to reach the event (AML or death), where time to reach AML was calculated as the number of days from the day the participant received the first dose of IV decitabine, oral decitabine + E7727, or the FDC tablet to the date of death or the date of MDS progression to AML as defined by ≥20% blasts in bone marrow or peripheral blood using the World Health Organization classification. Time to AML or death was censored on the last date of contact if a participant was lost to follow up prior to reaching a time-to-event endpoint.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=7 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=50 Participants
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=30 Participants
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants to Reach Acute Myeloid Leukemia (AML) or Death
Event
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
28 Participants
|
19 Participants
|
|
Number of Participants to Reach Acute Myeloid Leukemia (AML) or Death
Censored
|
4 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
11 Participants
|
22 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 32 monthsPopulation: The efficacy population includes all participants in Phase 1 and Phase 2 who received at least one dose of investigational product.
Overall survival was defined as the number of days from the day the participant received the first dose of IV decitabine, oral decitabine + E7727, or the FDC tablet to the date of death, regardless of cause.
Outcome measures
| Measure |
Phase 1 Dose Escalation Cohort 1
n=7 Participants
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 Participants
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 Participants
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 Participants
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 Participants
Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=50 Participants
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=30 Participants
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Overall Survival
Event
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
24 Participants
|
16 Participants
|
|
Number of Participants With Overall Survival
Censored
|
6 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
15 Participants
|
26 Participants
|
14 Participants
|
Adverse Events
Phase 1 Dose Escalation Cohort 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1 Dose Escalation Cohort 2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1 Dose Escalation Cohort 3
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1 Dose Escalation Cohort 4
Serious events: 6 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 1 Dose Escalation Cohort 5
Serious events: 14 serious events
Other events: 18 other events
Deaths: 5 deaths
Phase 2 Dose Confirmation
Serious events: 39 serious events
Other events: 48 other events
Deaths: 29 deaths
Phase 2 Fixed-Dose Combination
Serious events: 25 serious events
Other events: 30 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Phase 1 Dose Escalation Cohort 1
n=7 participants at risk
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 participants at risk
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 participants at risk
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 participants at risk
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 participants at risk
Cohort 1 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=50 participants at risk
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=30 participants at risk
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
34.0%
17/50 • Number of events 31 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
23.3%
7/30 • Number of events 10 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Malena
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Edema peripheral
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Sudden death
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
15.8%
3/19 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.0%
8/50 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
5/30 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
8.0%
4/50 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
5/50 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
26.7%
8/30 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Vertebral artery dissection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Pyomyositis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Subdural hemorrhage
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Oral infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Alpha hemolytic streptococcal infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
Other adverse events
| Measure |
Phase 1 Dose Escalation Cohort 1
n=7 participants at risk
Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 2
n=6 participants at risk
Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 3
n=6 participants at risk
Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 4
n=6 participants at risk
Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 1 Dose Escalation Cohort 5
n=19 participants at risk
Cohort 1 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
|
Phase 2 Dose Confirmation
n=50 participants at risk
Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
Phase 2 Fixed-Dose Combination
n=30 participants at risk
Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
57.1%
4/7 • Number of events 16 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
66.7%
4/6 • Number of events 11 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
52.6%
10/19 • Number of events 34 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
54.0%
27/50 • Number of events 67 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
15/30 • Number of events 59 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
3/7 • Number of events 13 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 12 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
66.7%
4/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
31.6%
6/19 • Number of events 24 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
56.0%
28/50 • Number of events 125 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
40.0%
12/30 • Number of events 53 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
57.1%
4/7 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
26.3%
5/19 • Number of events 16 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
32.0%
16/50 • Number of events 46 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
26.7%
8/30 • Number of events 23 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
21.1%
4/19 • Number of events 24 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
24.0%
12/50 • Number of events 47 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
36.7%
11/30 • Number of events 45 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
5/50 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
5/30 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Eye disorders
Diplopia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Eye disorders
Eye irritation
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Eye disorders
Eye pruritus
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Eye disorders
Conjunctival hemorrhage
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
83.3%
5/6 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
36.8%
7/19 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
34.0%
17/50 • Number of events 24 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
40.0%
12/30 • Number of events 15 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
66.7%
4/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
26.3%
5/19 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
26.0%
13/50 • Number of events 20 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
46.7%
14/30 • Number of events 18 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
38.0%
19/50 • Number of events 28 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
30.0%
9/30 • Number of events 11 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
15.8%
3/19 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
8.0%
4/50 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
5/30 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
26.7%
8/30 • Number of events 10 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
28.6%
2/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
20.0%
6/30 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Fatigue
|
28.6%
2/7 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
83.3%
5/6 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
83.3%
5/6 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
31.6%
6/19 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
46.0%
23/50 • Number of events 37 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
40.0%
12/30 • Number of events 15 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Edema peripheral
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
21.1%
4/19 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
26.0%
13/50 • Number of events 16 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
14.0%
7/50 • Number of events 13 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
23.3%
7/30 • Number of events 9 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Edema
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Asthenia
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
14.0%
7/50 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
30.0%
9/30 • Number of events 12 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Chills
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Catheter site erythema
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Generalized edema
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway cough syndrome
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
8.0%
4/50 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
8.0%
4/50 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Eye infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Furuncle
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Heliobacter infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
14.3%
1/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Otitis externa
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Rash pustular
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Tooth infection
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
8.0%
4/50 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Vaginal infection
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
18.0%
9/50 • Number of events 12 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
5/30 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
14.0%
7/50 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
13.3%
4/30 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
8.0%
4/50 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Iliotibial band syndrome
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
26.3%
5/19 • Number of events 10 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
22.0%
11/50 • Number of events 22 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
13.3%
4/30 • Number of events 9 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
13.3%
4/30 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
21.1%
4/19 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
14.0%
7/50 • Number of events 10 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
20.0%
6/30 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
15.8%
3/19 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.0%
8/50 • Number of events 10 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
13.3%
4/30 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
21.1%
4/19 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
18.0%
9/50 • Number of events 18 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
28.6%
2/7 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
5/50 • Number of events 9 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
13.3%
4/30 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 11 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Alanine aminotransferase decreased
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Blood urea increased
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Electrocardiogram repolarization abnormality
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Weight increased
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
2/7 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
24.0%
12/50 • Number of events 23 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
5/30 • Number of events 13 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
26.3%
5/19 • Number of events 9 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
20.0%
10/50 • Number of events 13 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
20.0%
6/30 • Number of events 12 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
15.8%
3/19 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
5/50 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
20.0%
6/30 • Number of events 9 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
26.3%
5/19 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
14.0%
7/50 • Number of events 16 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 13 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
5/30 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
15.8%
3/19 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.0%
8/50 • Number of events 12 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
23.3%
7/30 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
8.0%
4/50 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
20.0%
10/50 • Number of events 13 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 9 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
15.8%
3/19 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
22.0%
11/50 • Number of events 15 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
13.3%
4/30 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
28.6%
2/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
8.0%
4/50 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
5/30 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
24.0%
12/50 • Number of events 15 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
10/30 • Number of events 13 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
13.3%
4/30 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
21.1%
4/19 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 12 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
23.3%
7/30 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
28.0%
14/50 • Number of events 19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
43.3%
13/30 • Number of events 14 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Hypoasthesia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Lethargy
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
15.8%
3/19 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
13.3%
4/30 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
14.0%
7/50 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
24.0%
12/50 • Number of events 14 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
23.3%
7/30 • Number of events 8 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
21.1%
4/19 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
24.0%
12/50 • Number of events 15 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
23.3%
7/30 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
20.0%
6/30 • Number of events 10 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
42.9%
3/7 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
12.0%
6/50 • Number of events 15 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
5/30 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
5/50 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
15.8%
3/19 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
8.0%
4/50 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
14.3%
1/7 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
13.3%
4/30 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.5%
2/19 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
3/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Seborrheic dermatitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
2.0%
1/50 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
15.8%
3/19 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
5/30 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Hematoma
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
10.0%
5/50 • Number of events 6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
4.0%
2/50 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 3 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
8.0%
4/50 • Number of events 5 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.7%
2/30 • Number of events 2 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
6.0%
3/50 • Number of events 4 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
3.3%
1/30 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Gastrointestinal disorders
Trichoglossia
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Gasdtroenteritis viral
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Investigations
Troponin increased
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
14.3%
1/7 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/19 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/7 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/6 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
5.3%
1/19 • Number of events 1 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/50 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
0.00%
0/30 • Up to 5 years
Treatment-emergent adverse events were recorded from the start of study treatment until 30 days after the last dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place