Trial Outcomes & Findings for A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001) (NCT NCT01358331)
NCT ID: NCT01358331
Last Updated: 2020-04-02
Results Overview
DLT was derived from the toxicities observed during the first cycle (28 days) for each dose level. DLT is defined as any hematologic or non-hematologic toxicity ≥Grade 3 as pre-specified per protocol, or drug-related toxicity, regardless of Common Terminology Criteria for Adverse Events (CTCAE) grade that causes \>20% of the intended total number of doses in Cycle 1 to be missed.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Cycles of 28 days, up to approximately 9 months treatment and a 30-day follow-up period for a total time of up to approximately 10 months
Results posted on
2020-04-02
Participant Flow
25 participants were enrolled, received at least 1 dose of MK-8353 and were included in the analysis.
Participant milestones
| Measure |
MK-8353 100 mg Twice Daily (BID)
Participants received 100 mg twice daily for 28 days during each cycle
|
MK-8353 200 mg BID
Participants received 200 mg twice daily for 28 days during each cycle
|
MK-8353 300 mg BID
Participants received 300 mg twice daily for 28 days during each cycle
|
MK-8353 350 mg BID
Participants received 350 mg twice daily for 28 days during each cycle
|
MK-8353 400 mg BID
Participants received 400 mg twice daily for 28 days during each cycle
|
MK-8353 800 mg BID
Participants received 800 mg twice daily for 28 days during each cycle
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
4
|
3
|
7
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
3
|
7
|
6
|
Reasons for withdrawal
| Measure |
MK-8353 100 mg Twice Daily (BID)
Participants received 100 mg twice daily for 28 days during each cycle
|
MK-8353 200 mg BID
Participants received 200 mg twice daily for 28 days during each cycle
|
MK-8353 300 mg BID
Participants received 300 mg twice daily for 28 days during each cycle
|
MK-8353 350 mg BID
Participants received 350 mg twice daily for 28 days during each cycle
|
MK-8353 400 mg BID
Participants received 400 mg twice daily for 28 days during each cycle
|
MK-8353 800 mg BID
Participants received 800 mg twice daily for 28 days during each cycle
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Adverse Events
|
1
|
1
|
1
|
0
|
1
|
5
|
|
Overall Study
Symptomatic Deterioration
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Participants did not wish to continue
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Progress of disease under investigation
|
1
|
2
|
3
|
1
|
3
|
0
|
Baseline Characteristics
A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001)
Baseline characteristics by cohort
| Measure |
MK-8353 100 mg Twice Daily (BID)
n=2 Participants
Participants received 100 mg twice daily for 28 days during each cycle
|
MK-8353 200 mg BID
n=3 Participants
Participants received 200 mg twice daily for 28 days during each cycle
|
MK-8353 300 mg BID
n=4 Participants
Participants received 300 mg twice daily for 28 days during each cycle
|
MK-8353 350 mg BID
n=3 Participants
Participants received 350 mg twice daily for 28 days during each cycle
|
MK-8353 400 mg BID
n=7 Participants
Participants received 400 mg twice daily for 28 days during each cycle
|
MK-8353 800 mg BID
n=6 Participants
Participants received 800 mg twice daily for 28 days during each cycle
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
59.3 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
59.8 years
STANDARD_DEVIATION 9.0 • n=8 Participants
|
59.5 years
STANDARD_DEVIATION 9.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Cycles of 28 days, up to approximately 9 months treatment and a 30-day follow-up period for a total time of up to approximately 10 monthsPopulation: Analysis population includes all participants who received at least one dose of MK-8353 and completed Cycle 1 of Part 1 or discontinued due to toxicity. Participants who discontinued treatment due to reasons other than toxicity were not included.
DLT was derived from the toxicities observed during the first cycle (28 days) for each dose level. DLT is defined as any hematologic or non-hematologic toxicity ≥Grade 3 as pre-specified per protocol, or drug-related toxicity, regardless of Common Terminology Criteria for Adverse Events (CTCAE) grade that causes \>20% of the intended total number of doses in Cycle 1 to be missed.
Outcome measures
| Measure |
MK-8353 100 mg Twice Daily (BID)
n=2 Participants
Participants received 100 mg twice daily for 28 days during each cycle
|
MK-8353 200 mg BID
n=3 Participants
Participants received 200 mg twice daily for 28 days during each cycle
|
MK-8353 300 mg BID
n=4 Participants
Participants received 300 mg twice daily for 28 days during each cycle
|
MK-8353 350 mg BID
n=3 Participants
Participants received 350 mg twice daily for 28 days during each cycle
|
MK-8353 400 mg BID
n=6 Participants
Participants received 400 mg twice daily for 28 days during each cycle
|
MK-8353 800 mg BID
n=2 Participants
Participants received 800 mg twice daily for 28 days during each cycle
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
Grade 3 Maculopapular Rash
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
Grade 3 Diarrhea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
Grade 3 fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
Grade 3 nausea/vomiting/diarrhea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, and every 8 weeks until disease progression or discontinuation from study up to approximately 10 monthsPopulation: The analysis population is defined as all participants who received at least 1 dose of MK-8353 and had at least 1 post-baseline efficacy assessment. Participants who received at least one dose but had no post-baseline assessment were counted as "not evaluable" and were not included in this analysis.
Overall Response rate is defined as the number of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome measures
| Measure |
MK-8353 100 mg Twice Daily (BID)
n=2 Participants
Participants received 100 mg twice daily for 28 days during each cycle
|
MK-8353 200 mg BID
n=3 Participants
Participants received 200 mg twice daily for 28 days during each cycle
|
MK-8353 300 mg BID
n=4 Participants
Participants received 300 mg twice daily for 28 days during each cycle
|
MK-8353 350 mg BID
n=3 Participants
Participants received 350 mg twice daily for 28 days during each cycle
|
MK-8353 400 mg BID
n=6 Participants
Participants received 400 mg twice daily for 28 days during each cycle
|
MK-8353 800 mg BID
n=6 Participants
Participants received 800 mg twice daily for 28 days during each cycle
|
|---|---|---|---|---|---|---|
|
Number of Participants With Overall Response Rate
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Overall Response Rate
Partial Response
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Overall Response Rate
Partial Response Unconfirmed
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
MK-8353 100 mg Twice Daily (BID)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-8353 200 mg BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
MK-8353 300 mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
MK-8353 350 mg BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-8353 400 mg BID
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
MK-8353 800 mg BID
Serious events: 5 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
MK-8353 100 mg Twice Daily (BID)
n=2 participants at risk
Participants received 100 mg twice daily for 28 days during each cycle
|
MK-8353 200 mg BID
n=3 participants at risk
Participants received 200 mg twice daily for 28 days during each cycle
|
MK-8353 300 mg BID
n=4 participants at risk
Participants received 300 mg twice daily for 28 days during each cycle
|
MK-8353 350 mg BID
n=3 participants at risk
Participants received 350 mg twice daily for 28 days during each cycle
|
MK-8353 400 mg BID
n=7 participants at risk
Participants received 400 mg twice daily for 28 days during each cycle
|
MK-8353 800 mg BID
n=6 participants at risk
Participants received 800 mg twice daily for 28 days during each cycle
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
General disorders
FATIGUE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
General disorders
PAIN
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
General disorders
PYREXIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM PROGRESSION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
CONVULSION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
50.0%
1/2 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
MK-8353 100 mg Twice Daily (BID)
n=2 participants at risk
Participants received 100 mg twice daily for 28 days during each cycle
|
MK-8353 200 mg BID
n=3 participants at risk
Participants received 200 mg twice daily for 28 days during each cycle
|
MK-8353 300 mg BID
n=4 participants at risk
Participants received 300 mg twice daily for 28 days during each cycle
|
MK-8353 350 mg BID
n=3 participants at risk
Participants received 350 mg twice daily for 28 days during each cycle
|
MK-8353 400 mg BID
n=7 participants at risk
Participants received 400 mg twice daily for 28 days during each cycle
|
MK-8353 800 mg BID
n=6 participants at risk
Participants received 800 mg twice daily for 28 days during each cycle
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
50.0%
1/2 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
TACHYCARDIA
|
50.0%
1/2 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Eye disorders
VITREOUS FLOATERS
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
75.0%
3/4 • Number of events 3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
100.0%
3/3 • Number of events 4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
66.7%
4/6 • Number of events 4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
ERUCTATION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
66.7%
4/6 • Number of events 4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
General disorders
CHILLS
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
General disorders
FATIGUE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
42.9%
3/7 • Number of events 5 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
General disorders
PAIN
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
General disorders
PYREXIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
50.0%
1/2 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
BLOOD BILIRUBIN
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
BLOOD CREATININE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
BLOOD CREATININE ABNORMAL
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
75.0%
3/4 • Number of events 3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
BLOOD UREA INCREASED
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
50.0%
1/2 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
50.0%
1/2 • Number of events 3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
AMNESIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
DISORIENTATION
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
28.6%
2/7 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
INCONTINENCE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
50.0%
1/2 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
50.0%
1/2 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
25.0%
1/4 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
50.0%
1/2 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
RASH
|
50.0%
1/2 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
50.0%
2/4 • Number of events 9 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
42.9%
3/7 • Number of events 6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
14.3%
1/7 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
LYMPHOEDEMA
|
0.00%
0/2 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/4 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/3 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/7 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • 28-days per cycle up to 9 months plus a 30-day follow-up period for a total of approximately up to 10 months.
Analysis population consists of all participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication, presentation, or any media that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER