Trial Outcomes & Findings for A Study of LAM-003 in Patients With Acute Myeloid Leukemia (NCT NCT03426605)
NCT ID: NCT03426605
Last Updated: 2024-05-03
Results Overview
A primary objective was to determine the LAM-003 MTD and/or recommended dosing regimen (RDR) based on the pattern of dose-limiting toxicities (DLTs) in Cycle 1 of therapy. MTD as determined by DLTs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
At the end of the 28-day observation period for Cycle 1.
Results posted on
2024-05-03
Participant Flow
This study was conducted by 6 investigators located in medical centers throughout the United States.
The study included a screening period (up to 28 days) prior to the study drug administration period. Discontinuation of prior antitumor therapy was required except that subjects with rapidly proliferative disease could receive AML cytoreduction with hydroxyurea, cytarabine, and/or cyclophosphamide before the start of LAM-003 and during Cycle 1 of LAM-003 administration.
Participant milestones
| Measure |
LAM-003 200 mg QD
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4.
|
LAM-003 600 mg QD
4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
* Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
* Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
4
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
4
|
4
|
Reasons for withdrawal
| Measure |
LAM-003 200 mg QD
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4.
|
LAM-003 600 mg QD
4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
* Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
* Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|
|
Overall Study
AML relapse or progression
|
2
|
1
|
2
|
2
|
|
Overall Study
Treatment failure
|
3
|
2
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of LAM-003 in Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
LAM-003 200 mg QD
n=6 Participants
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
n=3 Participants
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
n=4 Participants
4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4.
|
LAM-003 600 mg QD
n=4 Participants
4 Participant were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
* Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
* Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
34 years
n=7 Participants
|
75 years
n=5 Participants
|
67.5 years
n=4 Participants
|
68 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
BMI
|
32.4 kg/m^2
n=5 Participants
|
27.6 kg/m^2
n=7 Participants
|
27.5 kg/m^2
n=5 Participants
|
21.6 kg/m^2
n=4 Participants
|
27.6 kg/m^2
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 = Fully active
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 = Restricted in physically strenuous activity but ambulatory
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 = Ambulatory and capable of all self-care but unable to carry out any work activities
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Elevated peripheral blood AML blast %
|
24.75 percentage
n=5 Participants
|
41.40 percentage
n=7 Participants
|
22.15 percentage
n=5 Participants
|
34.05 percentage
n=4 Participants
|
30.40 percentage
n=21 Participants
|
|
Number of prior anticancer treatment regimens
|
3.0 number of treatments
n=5 Participants
|
4.0 number of treatments
n=7 Participants
|
3.5 number of treatments
n=5 Participants
|
4.0 number of treatments
n=4 Participants
|
4.0 number of treatments
n=21 Participants
|
PRIMARY outcome
Timeframe: At the end of the 28-day observation period for Cycle 1.Population: Participants were considered evaluable for Cycle 1 DLT assessment if they either had a Cycle 1 DLT or completed 21/28 study drug doses during Cycle 1 and were observed ≥4 weeks from the start of study drug administration without having a DLT.
A primary objective was to determine the LAM-003 MTD and/or recommended dosing regimen (RDR) based on the pattern of dose-limiting toxicities (DLTs) in Cycle 1 of therapy. MTD as determined by DLTs.
Outcome measures
| Measure |
LAM-003 200 mg QD
n=3 Participants
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
n=3 Participants
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
n=3 Participants
4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4.
|
LAM-003 600 mg QD
n=3 Participants
4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
* Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
* Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
SECONDARY outcome
Timeframe: Weekly during the first 4 weeks and then every 4 weeks for up to 48 weeks.Population: All participants who received ≥1 dose of study drug.
Number and percentage of participants with an adverse event (AE).
Outcome measures
| Measure |
LAM-003 200 mg QD
n=6 Participants
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
n=3 Participants
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
n=4 Participants
4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4.
|
LAM-003 600 mg QD
n=4 Participants
4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
* Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
* Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|
|
Adverse Event Assessment
With ≥1 SAE
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Adverse Event Assessment
With ≥1 TEAE of Grade ≥3
|
5 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Adverse Event Assessment
With ≥1 study-drug-related TEAE of Grade ≥3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Event Assessment
With ≥1 treatment-emergent SAE
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Adverse Event Assessment
With ≥1 study-drug-related treatment-emergent SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Event Assessment
With ≥1 AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Event Assessment
With AEs resulting in drug interruption of study drug
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Adverse Event Assessment
With AEs (other than AML progression) resulting in permanent discontinuation of study drug
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Event Assessment
With AEs resulting in death within 30 days from the last dose of study drug
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Adverse Event Assessment
With ≥1 AE
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Adverse Event Assessment
With ≥1 TEAE
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Adverse Event Assessment
With ≥1 study-drug-related TEAE
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days)Population: The Pharmacokinetic (PK) population included all evaluable participants who were dosed and had sufficient concentration-time data to estimate at least one of the planned PK parameters, as determined by the study pharmacokineticist.
The pharmacokinetic parameter Cmax was determined in plasma for the active metabolite of LAM-003A and LAM-003 (prodrug)
Outcome measures
| Measure |
LAM-003 200 mg QD
n=6 Participants
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
n=3 Participants
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
n=4 Participants
4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4.
|
LAM-003 600 mg QD
n=4 Participants
4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
* Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
* Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
LAM-003A Day 1
|
3550 ng/mL
Standard Deviation 1860
|
8360 ng/mL
Standard Deviation 2230
|
9170 ng/mL
|
8240 ng/mL
Standard Deviation 3750
|
|
Maximum Plasma Concentration (Cmax)
LAM-003A Day 8
|
5000 ng/mL
Standard Deviation 576
|
8360 ng/mL
Standard Deviation 1150
|
8500 ng/mL
|
9620 ng/mL
Standard Deviation 3810
|
|
Maximum Plasma Concentration (Cmax)
LAM-003 Day 1
|
0.560 ng/mL
Standard Deviation 0.320
|
1.47 ng/mL
Standard Deviation 1.28
|
2.71 ng/mL
|
1.83 ng/mL
Standard Deviation 1.30
|
|
Maximum Plasma Concentration (Cmax)
LAM-003 Day 8
|
0.617 ng/mL
Standard Deviation 0.220
|
1.08 ng/mL
Standard Deviation 1.36
|
3.60 ng/mL
|
1.45 ng/mL
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days)Population: The PK population included all evaluable participants who were dosed and had sufficient concentration-time data to estimate at least one of the planned PK parameters, as determined by the study pharmacokineticist.
The pharmacokinetic parameter Tmax was determined in plasma for the active metabolite of LAM-003A and LAM-003 (prodrug)
Outcome measures
| Measure |
LAM-003 200 mg QD
n=6 Participants
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
n=3 Participants
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
n=1 Participants
4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4.
|
LAM-003 600 mg QD
n=4 Participants
4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
* Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
* Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|
|
Time of Maximum Concentration [Tmax]
LAM-003A for Day 1
|
3.80 hours
Interval 1.0 to 4.0
|
3.80 hours
Interval 1.8 to 4.0
|
4.10 hours
Interval 4.1 to 4.1
|
1.95 hours
Interval 1.9 to 23.3
|
|
Time of Maximum Concentration [Tmax]
LAM-003A for Day 8
|
2.00 hours
Interval 1.8 to 4.0
|
4.00 hours
Interval 4.0 to 5.8
|
2.10 hours
Interval 2.1 to 2.1
|
1.95 hours
Interval 1.1 to 2.0
|
|
Time of Maximum Concentration [Tmax]
LAM-003 for Day 1
|
1.00 hours
Interval 0.5 to 1.0
|
1.80 hours
Interval 0.8 to 2.0
|
0.50 hours
Interval 0.5 to 0.5
|
0.50 hours
Interval 0.4 to 1.0
|
|
Time of Maximum Concentration [Tmax]
LAM-003 for Day 8
|
0.75 hours
Interval 0.5 to 1.0
|
1.10 hours
Interval 0.5 to 1.1
|
0.50 hours
Interval 0.5 to 0.5
|
1.10 hours
Interval 0.6 to 3.0
|
SECONDARY outcome
Timeframe: Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days)Population: The PK population included all evaluable participants who were dosed and had sufficient concentration-time data to estimate at least one of the planned PK parameters, as determined by the study pharmacokineticist.
The pharmacokinetic parameter area under the concentration-time curve was determined in plasma for the active metabolite of LAM-003A and LAM-003 (prodrug). AUClast is the area under the concentration-time curve from time-zero to the time of the last quantifiable concentration. AUCtau is the area under the concentration-time curve during the dosing interval where tau=24hours for once daily (QD) dosing. AUCtau was not calculated for LAM-003.
Outcome measures
| Measure |
LAM-003 200 mg QD
n=6 Participants
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
n=3 Participants
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
n=1 Participants
4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4.
|
LAM-003 600 mg QD
n=4 Participants
4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
* Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
* Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|
|
Area Under the Curve [AUC]
LAM-003A AUClast for Day 1
|
43100 h*ng/mL
Standard Deviation 23200
|
112000 h*ng/mL
Standard Deviation 45100
|
131000 h*ng/mL
|
105000 h*ng/mL
Standard Deviation 39800
|
|
Area Under the Curve [AUC]
LAM-003A AUClast for Day 8
|
24400 h*ng/mL
Standard Deviation 5680
|
53600 h*ng/mL
Standard Deviation 10400
|
52800 h*ng/mL
|
56400 h*ng/mL
Standard Deviation 18000
|
|
Area Under the Curve [AUC]
LAM-003 AUClast for Day 1
|
0.287 h*ng/mL
Standard Deviation 0.254
|
0.958 h*ng/mL
Standard Deviation 0.745
|
1.72 h*ng/mL
|
0.935 h*ng/mL
Standard Deviation 1.10
|
|
Area Under the Curve [AUC]
LAM-003 AUClast for Day 8
|
0.383 h*ng/mL
Standard Deviation 0.311
|
1.18 h*ng/mL
Standard Deviation 1.84
|
0.90 h*ng/mL
|
0.833 h*ng/mL
Standard Deviation 0.837
|
|
Area Under the Curve [AUC]
LAM-003A AUCtau for Day 1
|
26000 h*ng/mL
Standard Deviation 43900
|
113000 h*ng/mL
Standard Deviation 46100
|
132000 h*ng/mL
|
110000 h*ng/mL
Standard Deviation 47300
|
|
Area Under the Curve [AUC]
LAM-003A AUCtau for Day 8
|
42300 h*ng/mL
Standard Deviation 4840
|
—
|
113000 h*ng/mL
|
103000 h*ng/mL
Standard Deviation 33900
|
SECONDARY outcome
Timeframe: Every 8 to 12 weeks for up to 48 weeks.Population: All participants who received ≥1 dose of study drug.
Tumor response by AML response criteria (Cheson 2003).
Outcome measures
| Measure |
LAM-003 200 mg QD
n=6 Participants
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
n=3 Participants
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
n=4 Participants
4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4.
|
LAM-003 600 mg QD
n=4 Participants
4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
* Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
* Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|
|
Objective Response Rate
CRc: Composite complete remission including participants with CR, CRMRD-, and CRi
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate
Treatment Failure
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Objective Response Rate
Disease Relapse or Progression
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Objective Response Rate
Nonevaluable
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 8 to 12 weeks for up to 48 weeks.Population: All participants who received ≥1 dose of study drug.
Event-free survival (EFS), defined as the interval from the start of study therapy to the earliest of the first documentation of disease relapse, disease progression, treatment failure (TF), or death from any cause. Overall survival (OS), defined as the interval from the start of study therapy to death from any cause.
Outcome measures
| Measure |
LAM-003 200 mg QD
n=6 Participants
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
n=3 Participants
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
n=4 Participants
4 participants were accrued at 450 mg QD. Intrasubject dose escalations were implemented in 1 subject. Subject 006-006 received LAM-003 450 mg QD during Cycles 1 and 2 and received LAM-003 600 mg QD during Cycles 3 and 4.
|
LAM-003 600 mg QD
n=4 Participants
4 participants were accrued at 600 mg QD. Intrasubject dose escalations were implemented in 2 subjects:
* Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
* Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|
|
Event-Free Survival (EFS) and Overall Survival (OS)
EFS
|
0.6 months
Interval 0.1 to 1.9
|
0.9 months
Interval 0.7 to 1.2
|
1.8 months
Interval 0.3 to 3.5
|
1.5 months
Interval 0.6 to 2.9
|
|
Event-Free Survival (EFS) and Overall Survival (OS)
OS
|
3 months
Interval 0.3 to 3.2
|
5.1 months
Interval 1.0 to 5.9
|
3.4 months
Interval 0.8 to 5.5
|
3.1 months
Interval 1.6 to 4.3
|
Adverse Events
LAM-003 200 mg QD
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
LAM-003 300 mg QD
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
LAM-003 450 mg QD
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
LAM-003 600 mg QD
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
LAM-003 750 mg QD
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
LAM-003 200 mg QD
n=6 participants at risk
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
n=3 participants at risk
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
n=4 participants at risk
4 participants were accrued at 450 mg QD.
|
LAM-003 600 mg QD
n=4 participants at risk
4 participants were accrued at 600 mg QD.
|
LAM-003 750 mg QD
n=3 participants at risk
3 participants received 750 mg QD after intrasubject dose escalations.
• Subject 006-006 received LAM-003 450 mg QD during Cycles 1, 600 mg LAM-003 in Cycle 2 and received LAM-003 750 mg QD during Cycles 3 and 4.
Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
• Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|---|
|
General disorders
Disease Progression
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
50.0%
2/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Hemoglobin Decreased
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
WBC Count Increased
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Nervous system disorders
Cerebral Hemorrhage
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Nervous system disorders
Hemorrhage Intracranial
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
Other adverse events
| Measure |
LAM-003 200 mg QD
n=6 participants at risk
6 participants were accrued at starting dose level of 200 mg QD.
|
LAM-003 300 mg QD
n=3 participants at risk
3 participants were accrued at 300 mg QD.
|
LAM-003 450 mg QD
n=4 participants at risk
4 participants were accrued at 450 mg QD.
|
LAM-003 600 mg QD
n=4 participants at risk
4 participants were accrued at 600 mg QD.
|
LAM-003 750 mg QD
n=3 participants at risk
3 participants received 750 mg QD after intrasubject dose escalations.
• Subject 006-006 received LAM-003 450 mg QD during Cycles 1, 600 mg LAM-003 in Cycle 2 and received LAM-003 750 mg QD during Cycles 3 and 4.
Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3.
• Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2.
|
|---|---|---|---|---|---|
|
General disorders
Oedma peripheral
|
50.0%
3/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
50.0%
2/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
General disorders
Chills
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
General disorders
Disease progression
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
General disorders
Pain
|
33.3%
2/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
General disorders
Peripheral swelling
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Blood potassium decreased
|
33.3%
2/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Platelet count decreased
|
66.7%
4/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
White blood cell count increased
|
66.7%
4/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Blood glucose increased
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Hemoglobin decreased
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Blood potassium increased
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Ejection fraction decreased
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Tropoin T increased
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Investigations
Weight increased
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
50.0%
2/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
100.0%
3/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
2/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Plural effusion
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Metabolism and nutrition disorders
Decreased appetitie
|
33.3%
2/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
50.0%
2/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
50.0%
2/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
50.0%
2/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
2/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
66.7%
2/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Vascular disorders
Pallor
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Infections and infestations
Anal abcess
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Infections and infestations
Bacterial sepsis
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Infections and infestations
Laryngitis
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Injury, poisoning and procedural complications
Face injury
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Injury, poisoning and procedural complications
Hypobarism
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Eye disorders
Eye irritation
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Eye disorders
Eyelid pain
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia cutis
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
25.0%
1/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
|
Reproductive system and breast disorders
Scrotal irritation
|
0.00%
0/6 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
33.3%
1/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/4 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
0.00%
0/3 • Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER