Trial Outcomes & Findings for Study of PARPi 2X-121 as Monotherapy and in Combination With Dovitinib in Patients With Advanced Solid Tumors (NCT NCT05571969)
NCT ID: NCT05571969
Last Updated: 2026-06-01
Results Overview
To determine the maximum tolerated dose (MTD) of 2X-121 monotherapy given twice daily (BID) in patients with advanced solid tumors. The MTD was defined as one dose level below the dose in which DLTs were observed in at least 33% of participants in a Cohort during the first 14 days of the treatment period, after addition of subjects following the first reported DLT in a Cohort (if applicable). Therefore, the table below presents number of subjects with DLTs in each Cohort during the first 14 days of treatment.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
First 14 days in each Cohort
Results posted on
2026-06-01
Participant Flow
The first subject signed informed consent on 08 March 2023. Subjects were enrolled across three study centers. Due to study termination prior to Part 2, there were no subjects enrolled in Part 2 of this study.
Subjects were assessed for eligibility after signing the informed consent but prior to enrollment. Those that did not meet eligibility criteria were considered as screen failures. There was no wash out or run-in period during this study.
Participant milestones
| Measure |
2X-121 600 mg
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
8
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
1
|
Reasons for withdrawal
| Measure |
2X-121 600 mg
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
|
Overall Study
Progressive Disease
|
1
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
Baseline Characteristics
Study of PARPi 2X-121 as Monotherapy and in Combination With Dovitinib in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
2X-121 600 mg
n=5 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=8 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.2 Years
STANDARD_DEVIATION 18.97 • n=24 Participants
|
59.8 Years
STANDARD_DEVIATION 10.40 • n=24 Participants
|
64.0 Years
STANDARD_DEVIATION 0.0 • n=48 Participants
|
60.9 Years
STANDARD_DEVIATION 13.08 • n=100 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
6 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
8 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
14 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
12 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: First 14 days in each CohortTo determine the maximum tolerated dose (MTD) of 2X-121 monotherapy given twice daily (BID) in patients with advanced solid tumors. The MTD was defined as one dose level below the dose in which DLTs were observed in at least 33% of participants in a Cohort during the first 14 days of the treatment period, after addition of subjects following the first reported DLT in a Cohort (if applicable). Therefore, the table below presents number of subjects with DLTs in each Cohort during the first 14 days of treatment.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=5 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=8 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Determination of the MTD of 2X-121 Monotherapy (Number of Subjects With Dose-Limiting Toxicities)
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: First 14 days of each CohortPopulation: As the study was terminated prior to Part 2, there were no subjects enrolled in Part 2 of the study and therefore there are no data to report for this outcome measure.
To determine the maximum tolerated dose (MTD) of dovitinib when given in combination with the MTD of 2X-121 in patients with advanced solid tumors (Part 2 of the study). The MTD was defined as one dose level below the dose in which DLTs were observed in at least 33% of participants in a Cohort during the first 14 days of the treatment period, after addition of subjects following the first reported DLT in a Cohort (if applicable). Therefore, this outcome measure planned to evaluate the number of subjects with DLTs in each Cohort during the first 14 days of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment until end of follow-up.Population: Not analyzed for Part 2 - due to early study termination, there are no data to analyze for Part 2.
ORR is defined as the proportion of subjects who achieve a Complete Response (CR) or Partial Response (PR) as assessed by RECIST v1.1. Response was evaluated approximately every 8 weeks during the study.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=5 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=8 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) of 2X-121 Monotherapy (Part 1) and in Combination With Dovitinib (Part 2).
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From enrollment until end of follow-up.Population: Not analyzed for Part 1 - no subject had complete or partial response. And, as study was terminated early and the primary objective for Part 1 was not related to efficacy, statistical analysis of Part 1 efficacy data was not performed. Not analyzed for Part 2 - due to early study termination, there are no data to analyze for Part 2.
Duration of response is defined as the time in months from the first documented complete response or partial response per RECIST v1.1 to disease recurrence of progressive disease, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment until end of follow-up.Population: Not analyzed for Part 2 - due to early study termination, there are no data to analyze for Part 2.
PFS is defined as the time in months from study treatment initiation to either first observation of progressive disease or death.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=5 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=8 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) of 2X-121 Monotherapy (Part 1) and in Combination With Dovitinib (Part 2).
|
—
|
—
|
5.1 Months
Standard Deviation 5.45
|
3.3 Months
Standard Deviation 2.30
|
1.0 Months
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: From enrollment until follow-up.Population: Not analyzed for Part 2 - due to early study termination, there are no data to analyze for Part 2.
Overall survival is defined as the time in months from study treatment initiation to death from any cause or last day known to be alive.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=5 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=8 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) of 2X-121 Monotherapy (Part 1) and in Combination With Dovitinib (Part 2).
|
—
|
—
|
7.0 Months
Standard Deviation 4.58
|
4.8 Months
Standard Deviation 3.41
|
1.0 Months
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1Population: There were two sets of PK results prepared as one subject in the 2X-121 800 mg arm may have had their C1D1 pre-dose and 1hr post-dose samples swapped (suspected based on a high C1D1 pre-dose concentration and 'below limit of quantification' post-dose concentration). Method 1 excludes this subject and Method 2 includes the subject with the consideration that samples were swapped (therefore switching C1D1 pre-dose and 1-hr post-dose concentrations in analysis).
PK samples were collected at Cycle 1, Day 1 (prior to drug administration and 1-, 3-, 4-, 6-, and 12-hours after drug administration) Cycle 1, Day 2 (prior to drug administration), Cycle 1, Day 7 (prior to drug administration), Cycle 1, Day 15 (prior to drug administration), and on the first day of all subsequent cycles (prior to drug administration). PK parameters are calculated based on Cycle 1, Day 1 PK samples.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=5 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=8 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Maximum Concentration of 2X-121 (Cmax)
Method 1
|
—
|
—
|
679 ng/mL
Standard Deviation 447
|
1430 ng/mL
Standard Deviation 900
|
746 ng/mL
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
|
Maximum Concentration of 2X-121 (Cmax)
Method 2
|
—
|
—
|
679 ng/mL
Standard Deviation 447
|
1640 ng/mL
Standard Deviation 1030
|
746 ng/mL
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1Population: There were two sets of PK results prepared as one subject in the 2X-121 800 mg arm may have had their C1D1 pre-dose and 1hr post-dose samples swapped (suspected based on a high C1D1 pre-dose concentration and 'below limit of quantification' post-dose concentration). Method 1 excludes this subject and Method 2 includes the subject with the consideration that samples were swapped (therefore switching C1D1 pre-dose and 1-hr post-dose concentrations in analysis).
PK samples were collected at Cycle 1, Day 1 (prior to drug administration and 1-, 3-, 4-, 6-, and 12-hours after drug administration) Cycle 1, Day 2 (prior to drug administration), Cycle 1, Day 7 (prior to drug administration), Cycle 1, Day 15 (prior to drug administration), and on the first day of every subsequent cycle (prior to drug administration). PK parameters are calculated based on Cycle 1, Day 1 PK samples.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=5 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=8 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma-time Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)
Method 1
|
—
|
—
|
2440 h*ng/mL
Standard Deviation 768
|
4280 h*ng/mL
Standard Deviation 1320
|
3140 h*ng/mL
Standard Deviation NA
not calculated - only one subject in the arm
|
—
|
|
Area Under the Plasma-time Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)
Method 2
|
—
|
—
|
2440 h*ng/mL
Standard Deviation 768
|
4520 h*ng/mL
Standard Deviation 1410
|
3140 h*ng/mL
Standard Deviation NA
not calculated - only one subject in the arm
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1Population: There were two sets of PK results prepared as one subject in the 2X-121 800 mg arm may have had their C1D1 pre-dose and 1hr post-dose samples swapped (suspected based on a high C1D1 pre-dose concentration and 'below limit of quantification' post-dose concentration). Method 1 excludes this subject and Method 2 includes the subject with the consideration that samples were swapped. Additionally, AUC0-inf could not be calculated for subjects with less than 3 PK samples after Cmax.
PK samples were collected at Cycle 1, Day 1 (prior to drug administration and 1-, 3-, 4-, 6-, and 12-hours after drug administration) Cycle 1, Day 2 (prior to drug administration), Cycle 1, Day 7 (prior to drug administration), Cycle 1, Day 15 (prior to drug administration), and on the first day of every subsequent cycle (prior to drug administration). PK parameters are calculated based on Cycle 1, Day 1 samples.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=2 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=5 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma-time Concentration Curve From Time 0 to Infinity (AUC0-inf)
Method 2
|
—
|
—
|
2660 h*ng/mL
Standard Deviation 414
|
4580 h*ng/mL
Standard Deviation 1620
|
3200 h*ng/mL
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
|
Area Under the Plasma-time Concentration Curve From Time 0 to Infinity (AUC0-inf)
Method 1
|
—
|
—
|
2660 h*ng/mL
Standard Deviation 414
|
4140 h*ng/mL
Standard Deviation 1470
|
3200 h*ng/mL
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1Population: There were two sets of PK results prepared as one subject in the 2X-121 800 mg arm may have had their C1D1 pre-dose and 1hr post-dose samples swapped (suspected based on a high C1D1 pre-dose concentration and 'below limit of quantification' post-dose concentration). Method 1 excludes this subject and Method 2 includes the subject with the consideration that samples were swapped. Additionally, t1/2 could not be calculated for subjects with less than three PK samples after Cmax.
PK samples were collected at Cycle 1, Day 1 (prior to drug administration and 1-, 3-, 4-, 6-, and 12-hours after drug administration) Cycle 1, Day 2 (prior to drug administration), Cycle 1, Day 7 (prior to drug administration), Cycle 1, Day 15 (prior to drug administration), and on the first day of every subsequent cycle (prior to drug administration). PK parameters are calculated based on Cycle 1, Day 1 PK samples.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=2 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=5 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Elimination Half-life of 2X-121 (t1/2)
Method 1
|
—
|
—
|
2.26 hours
Standard Deviation 0.493
|
2.69 hours
Standard Deviation 0.685
|
1.74 hours
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
|
Elimination Half-life of 2X-121 (t1/2)
Method 2
|
—
|
—
|
2.26 hours
Standard Deviation 0.493
|
2.58 hours
Standard Deviation 0.642
|
1.74 hours
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1Population: There were two sets of PK results prepared as one subject in the 2X-121 800 mg arm may have had their C1D1 pre-dose and 1hr post-dose samples swapped (suspected based on a high C1D1 pre-dose concentration and 'below limit of quantification' post-dose concentration). Method 1 excludes this subject and Method 2 includes the subject with the consideration that samples were swapped.
PK samples were collected at Cycle 1, Day 1 (prior to drug administration and 1-, 3-, 4-, 6-, and 12-hours after drug administration) Cycle 1, Day 2 (prior to drug administration), Cycle 1, Day 7 (prior to drug administration), Cycle 1, Day 15 (prior to drug administration), and on the first day of every subsequent cycle (prior to drug administration). PK parameters are calculated based on Cycle 1, Day 1 PK samples.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=5 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=8 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
Method 1
|
—
|
—
|
2.92 hours
Standard Deviation 1.24
|
2.69 hours
Standard Deviation 1.91
|
2.80 hours
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
|
Time to Maximum Plasma Concentration (Tmax)
Method 2
|
—
|
—
|
2.92 hours
Standard Deviation 1.24
|
2.47 hours
Standard Deviation 1.88
|
2.80 hours
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1Population: There were two sets of PK results prepared as one subject in the 2X-121 800 mg arm may have had their C1D1 pre-dose and 1hr post-dose samples swapped (suspected based on a high C1D1 pre-dose concentration and 'below limit of quantification' post-dose concentration). Method 1 excludes this subject and Method 2 includes the subject with the consideration that samples were swapped. Additionally, Cl/F could not be calculated for subjects with less than three PK samples after Cmax.
PK samples were collected at Cycle 1, Day 1 (prior to drug administration and 1-, 3-, 4-, 6-, and 12-hours after drug administration) Cycle 1, Day 2 (prior to drug administration), Cycle 1, Day 7 (prior to drug administration), Cycle 1, Day 15 (prior to drug administration), and on the first day of every subsequent cycle (prior to drug administration). PK parameters are calculated based on Cycle 1, Day 1 PK samples.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=2 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=5 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Total Body Clearance of 2X-121 (Cl/F)
Method 1
|
—
|
—
|
76100 mL/h
Standard Deviation 11900
|
106000 mL/h
Standard Deviation 37500
|
125000 mL/h
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
|
Total Body Clearance of 2X-121 (Cl/F)
Method 2
|
—
|
—
|
76100 mL/h
Standard Deviation 11900
|
97600 mL/h
Standard Deviation 37900
|
125000 mL/h
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1Population: There were two sets of PK results prepared as one subject in the 2X-121 800 mg arm may have had their C1D1 pre-dose and 1hr post-dose samples swapped (suspected based on a high C1D1 pre-dose concentration and 'below limit of quantification' post-dose concentration). Method 1 excludes this subject and Method 2 includes the subject with the consideration that samples were swapped. Additionally, Vz/F could not be calculated for subjects with less than three PK samples after Cmax.
PK samples were collected at Cycle 1, Day 1 (prior to drug administration and 1-, 3-, 4-, 6-, and 12-hours after drug administration) Cycle 1, Day 2 (prior to drug administration), Cycle 1, Day 7 (prior to drug administration), Cycle 1, Day 15 (prior to drug administration), and on the first day of every subsequent cycle (prior to drug administration). PK parameters are calculated based on Cycle 1, Day 1 PK samples.
Outcome measures
| Measure |
Combination 2X-121 + 400 mg Dovitinib
Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib. However, the study was terminated prior to Part 2.
|
Combination 2X-121 + 500 mg Dovitinib
Part 2 Cohort 3 was planned to receive 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib. However, the study was terminated prior to Part 2.
|
2X-121 600 mg
n=2 Participants
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=5 Participants
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 Participants
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
Combination 2X-121 + 300 mg Dovitinib
Part 2 Cohort 1 was planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib. However, the study was terminated prior to Part 2.
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
Method 1
|
—
|
—
|
244000 mL
Standard Deviation 15400
|
419000 mL
Standard Deviation 178000
|
315000 mL
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
|
Apparent Volume of Distribution (Vz/F)
Method 2
|
—
|
—
|
244000 mL
Standard Deviation 15400
|
374000 mL
Standard Deviation 184000
|
315000 mL
Standard Deviation NA
not calculated - only one subject in the arm.
|
—
|
Adverse Events
2X-121 600 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 4 deaths
2X-121 800 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 2 deaths
2X-121 1000 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2X-121 600 mg
n=5 participants at risk
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=8 participants at risk
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 participants at risk
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
|---|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
100.0%
1/1 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
General disorders
Death
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
Other adverse events
| Measure |
2X-121 600 mg
n=5 participants at risk
Subjects receiving 600 mg 2X-121 BID (200 mg morning + 400 mg evening)
|
2X-121 800 mg
n=8 participants at risk
Subjects receiving 800 mg 2X-121 BID (400 mg morning + 400 mg evening)
|
2X-121 1000 mg
n=1 participants at risk
Subjects receiving 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)
|
|---|---|---|---|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 7 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
37.5%
3/8 • Number of events 7 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
100.0%
1/1 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
General disorders
Pyrexia
|
40.0%
2/5 • Number of events 3 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
General disorders
Chills
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
General disorders
Gait disturbance
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 4 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 3 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • Number of events 2 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 2 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Nervous system disorders
Brain oedema
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Nervous system disorders
Cognitive disorder
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 2 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Eye disorders
Dry eye
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Eye disorders
Vision blurred
|
20.0%
1/5 • Number of events 3 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Eye disorders
Visual impairment
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
60.0%
3/5 • Number of events 10 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
100.0%
1/1 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Eye disorders
Flank pain
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
100.0%
1/1 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Psychiatric disorders
Depression
|
40.0%
2/5 • Number of events 2 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
100.0%
1/1 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Vascular disorders
Hypotension
|
40.0%
2/5 • Number of events 2 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Number of events 2 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Number of events 2 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Renal and urinary disorders
Chromaturia
|
40.0%
2/5 • Number of events 2 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Cardiac disorders
Tachycardia
|
40.0%
2/5 • Number of events 2 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
100.0%
1/1 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
1/5 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
20.0%
1/5 • Number of events 2 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/8 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/5 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
12.5%
1/8 • Number of events 1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
0.00%
0/1 • From enrollment until end of follow-up, up to approximately 1 year 3 months (15 months)
Treatment-emergent adverse events (TEAEs) are reported here. TEAEs are defined as AEs with a start date on or after the first administration of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI can publish and present results, provided that the Sponsor is given copies of any proposed publication or presentation at 30 days in advance of the submission of such proposed publication or presentation. Sponsor can object to the proposed publication/presentation, however approval will not be unreasonably withheld unless to protect proprietary/patent interests of the Sponsor or provide information to competitors that acts to reduce Sponsor's competitive edge in the marketplace.
- Publication restrictions are in place
Restriction type: OTHER