Trial Outcomes & Findings for A Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003) (NCT NCT02259114)
NCT ID: NCT02259114
Last Updated: 2021-01-26
Results Overview
A DLT was defined as any of the following toxicities that were considered by the investigator to be related to MK-8628: Hematologic toxicity: Grade 4 hematologic toxicity or febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with bleeding or lasting \>7 days; Non-hematologic toxicity: Grade 3 or 4 non-hematologic toxicity (regardless of duration) unless it was not optimally managed with supportive care, Grade 3 or 4 laboratory abnormality, with or without symptoms, lasting \>48 hours, Intolerable Grade 2 non-hematologic toxicity resulting in study drug discontinuation or delay \>7 days with or without dose reduction, Designated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver test abnormalities; Treatment delay \>2 weeks or dose reduction requirement for initiating Cycle 2.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Up to Cycle 1 Day 21 (Up to 21 days)
Results posted on
2021-01-26
Participant Flow
Participant milestones
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
Participants received MK-8628 (formerly OTX015) capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
4
|
13
|
3
|
6
|
|
Overall Study
Treated
|
20
|
4
|
13
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
21
|
4
|
13
|
3
|
6
|
Reasons for withdrawal
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
Participants received MK-8628 (formerly OTX015) capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
14
|
2
|
10
|
2
|
5
|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
0
|
1
|
|
Overall Study
Death
|
3
|
0
|
1
|
0
|
0
|
|
Overall Study
Treatment Delay >2 wks: Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Treatment Delay >2 wks: Toxicity
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Not Treated
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.2 Years
STANDARD_DEVIATION 18.8 • n=20 Participants
|
62.5 Years
STANDARD_DEVIATION 13.5 • n=4 Participants
|
64.3 Years
STANDARD_DEVIATION 9.5 • n=13 Participants
|
63.3 Years
STANDARD_DEVIATION 9.3 • n=3 Participants
|
58.5 Years
STANDARD_DEVIATION 5.3 • n=6 Participants
|
57.2 Years
STANDARD_DEVIATION 15.3 • n=46 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
7 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=20 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=13 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
39 Participants
n=46 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Up to Cycle 1 Day 21 (Up to 21 days)Population: The DLT Evaluable Population consisted of all participants who received ≥85% of the planned dose of study treatment (18 days for Continuous Dosing Regimens, or 6 days for Days 1-7 Dosing Regimens) or experienced a DLT during the first 21-day cycle.
A DLT was defined as any of the following toxicities that were considered by the investigator to be related to MK-8628: Hematologic toxicity: Grade 4 hematologic toxicity or febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with bleeding or lasting \>7 days; Non-hematologic toxicity: Grade 3 or 4 non-hematologic toxicity (regardless of duration) unless it was not optimally managed with supportive care, Grade 3 or 4 laboratory abnormality, with or without symptoms, lasting \>48 hours, Intolerable Grade 2 non-hematologic toxicity resulting in study drug discontinuation or delay \>7 days with or without dose reduction, Designated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver test abnormalities; Treatment delay \>2 weeks or dose reduction requirement for initiating Cycle 2.
Outcome measures
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)Population: The Safety Population consisted of all participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence associated with use of study treatment in humans, whether or not considered treatment related. The number of participants who experienced at least one AE is presented.
Outcome measures
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event (AE)
|
20 Participants
|
4 Participants
|
13 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 16.5 monthsPopulation: The Safety Population consisted of all participants who received at least one dose of study treatment.
The number of participants who discontinued study treatment due to an AE is presented.
Outcome measures
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
5 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 16.5 monthsPopulation: The Efficacy Population consisted of all participants who received ≥2 complete cycles (6 weeks) of study treatment and underwent baseline assessment and 1 on-study tumor assessment, or who discontinued early due to disease progression.
The best overall response was the best response recorded from the start of the study treatment until the end of treatment. RECIST 1.1 response categories included: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=19 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=2 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=12 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Best Overall Response as Assessed in Solid Tumors by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or in Castration-resistant Prostate Cancer (CRPC) by Prostate Cancer Clinical Trials Working Group (PCWG2) Response Criteria
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response as Assessed in Solid Tumors by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or in Castration-resistant Prostate Cancer (CRPC) by Prostate Cancer Clinical Trials Working Group (PCWG2) Response Criteria
Partial Response
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response as Assessed in Solid Tumors by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or in Castration-resistant Prostate Cancer (CRPC) by Prostate Cancer Clinical Trials Working Group (PCWG2) Response Criteria
Stable Disease
|
12 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
|
Best Overall Response as Assessed in Solid Tumors by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or in Castration-resistant Prostate Cancer (CRPC) by Prostate Cancer Clinical Trials Working Group (PCWG2) Response Criteria
Progressive Disease
|
4 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Best Overall Response as Assessed in Solid Tumors by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or in Castration-resistant Prostate Cancer (CRPC) by Prostate Cancer Clinical Trials Working Group (PCWG2) Response Criteria
Not Evaluable
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdosePopulation: The Pharmacokinetics (PK) Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.
Blood samples were obtained at specified time points for pharmacokinetic (PK) analysis of the observed Cmax of MK-8628. The observed Cmax of MK-8628 after administration is presented.
Outcome measures
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Observed Maximum Plasma Concentration (Cmax) of MK-8628
|
1466 μg/L
Standard Deviation 566
|
1867 μg/L
Standard Deviation 241
|
1514 μg/L
Standard Deviation 377
|
2052 μg/L
Standard Deviation 1130
|
2670 μg/L
Standard Deviation 741
|
SECONDARY outcome
Timeframe: Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdosePopulation: The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.
Blood samples were obtained at specified time points for PK analysis of the Tmax of MK-8628. The Tmax of MK-8628 after administration is presented.
Outcome measures
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of MK-8628
|
2.0 Hours
Standard Deviation 0.6
|
2.4 Hours
Standard Deviation 0.5
|
2.9 Hours
Standard Deviation 0.7
|
1.9 Hours
Standard Deviation 0.6
|
2.5 Hours
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdosePopulation: The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.
Blood samples were obtained at specified time points for PK analysis of the AUC0-∞ of MK-8628. The AUC0-first is AUC0-∞ which is derived from the post-hoc estimate of CL/F from the population model. The AUC0-∞ of MK-8628 after administration is presented.
Outcome measures
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Area Under to Concentration-Time Curve From 0 to Infinity (AUC0-∞) of MK-8628
|
12550 μg*h/L
Standard Deviation 4456
|
19130 μg*h/L
Standard Deviation 6543
|
12800 μg*h/L
Standard Deviation 3597
|
16210 μg*h/L
Standard Deviation 9551
|
27440 μg*h/L
Standard Deviation 10510
|
SECONDARY outcome
Timeframe: Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdosePopulation: The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.
Blood samples were obtained at specified time points for PK analysis of the Vdss of MK-8628. The Vdss of MK-8628 after administration is presented.
Outcome measures
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vdss) of MK-8628
|
44.9 Liters
Standard Deviation 13.4
|
44.3 Liters
Standard Deviation 5.59
|
46.9 Liters
Standard Deviation 9.2
|
44.0 Liters
Standard Deviation 18.3
|
41.6 Liters
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdosePopulation: The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.
Blood samples were obtained at specified time points for PK analysis of the t1/2 of MK-8628. The t1/2 of MK-8628 after administration is presented.
Outcome measures
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of MK-8628
|
4.53 Hours
Standard Deviation 0.866
|
5.93 Hours
Standard Deviation 2.46
|
3.97 Hours
Standard Deviation 0.46
|
3.52 Hours
Standard Deviation 0.593
|
3.99 Hours
Standard Deviation 0.664
|
SECONDARY outcome
Timeframe: Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdosePopulation: The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.
Blood samples were obtained at specified time points for PK analysis of the CL of MK-8628. The CL of MK-8628 after administration is presented.
Outcome measures
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 Participants
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 Participants
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 Participants
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 Participants
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Total Plasma Clearance (CL) of MK-8628
|
6.98 Liters/Hour
Standard Deviation 1.98
|
5.69 Liters/Hour
Standard Deviation 1.87
|
8.36 Liters/Hour
Standard Deviation 2.16
|
8.97 Liters/Hour
Standard Deviation 4.02
|
7.39 Liters/Hour
Standard Deviation 2.76
|
Adverse Events
MK-8628 Continuous Dosing Regimen 80 mg/Day
Serious events: 15 serious events
Other events: 20 other events
Deaths: 3 deaths
MK-8628 Continuous Dosing Regimen 100 mg/Day
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
Serious events: 5 serious events
Other events: 13 other events
Deaths: 1 deaths
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 participants at risk
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 participants at risk
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 participants at risk
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 participants at risk
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 participants at risk
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 7 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 5 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Pain
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Spinal cord infection
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Platelet count decreased
|
20.0%
4/20 • Number of events 5 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
2/20 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Spinal cord compression
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
4/20 • Number of events 4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
MK-8628 Continuous Dosing Regimen 80 mg/Day
n=20 participants at risk
Participants received MK-8628 capsules at a total daily dose of 80 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Continuous Dosing Regimen 100 mg/Day
n=4 participants at risk
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 100 mg/Day
n=13 participants at risk
Participants received MK-8628 capsules at a total daily dose of 100 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 120 mg/Day
n=3 participants at risk
Participants received MK-8628 capsules at a total daily dose of 120 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
MK-8628 Days 1-7 Dosing Regimen 160 mg/Day
n=6 participants at risk
Participants received MK-8628 capsules at a total daily dose of 160 mg/day once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
35.0%
7/20 • Number of events 19 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
4/20 • Number of events 10 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Congenital, familial and genetic disorders
Factor VII deficiency
|
20.0%
4/20 • Number of events 4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Vision blurred
|
10.0%
2/20 • Number of events 5 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
35.0%
7/20 • Number of events 10 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
66.7%
4/6 • Number of events 4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
3/20 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
53.8%
7/13 • Number of events 14 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
100.0%
3/3 • Number of events 5 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
100.0%
6/6 • Number of events 17 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
4/20 • Number of events 4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
45.0%
9/20 • Number of events 15 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
38.5%
5/13 • Number of events 6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
100.0%
3/3 • Number of events 10 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
83.3%
5/6 • Number of events 10 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
1/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
5/20 • Number of events 12 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
46.2%
6/13 • Number of events 9 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 8 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
50.0%
10/20 • Number of events 14 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
46.2%
6/13 • Number of events 8 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 12 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Chest pain
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Crying
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
15.0%
3/20 • Number of events 6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 12 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Localised oedema
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes zoster
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Mucosal infection
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Spinal cord infection
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
15.0%
3/20 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
2/20 • Number of events 4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Coagulation factor VII level increased
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Platelet count decreased
|
25.0%
5/20 • Number of events 27 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
35.0%
7/20 • Number of events 9 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
8/20 • Number of events 13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
30.8%
4/13 • Number of events 5 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
83.3%
5/6 • Number of events 12 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
2/20 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.0%
1/20 • Number of events 4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
5/20 • Number of events 6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
23.1%
3/13 • Number of events 8 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
4/20 • Number of events 4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Tremor
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
4/20 • Number of events 5 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
8/20 • Number of events 10 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
66.7%
4/6 • Number of events 5 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.0%
3/20 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
15.4%
2/13 • Number of events 3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
3/20 • Number of events 4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hot flush
|
10.0%
2/20 • Number of events 2 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/13 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Subject to obligations of confidentiality, the investigator reserves the right to publish only the results of the work performed pursuant to this protocol, provided, however, that the investigator provides an authorized representative of the Sponsor with a copy of any proposed publication for review and comment at least 45 days in advance of its submission for publication.
- Publication restrictions are in place
Restriction type: OTHER