Trial Outcomes & Findings for A Dose Escalation Study of MLN7243 (TAK-243) in Adult Participants With Advanced Solid Tumors (NCT NCT02045095)
NCT ID: NCT02045095
Last Updated: 2019-03-14
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Baseline up to 30 days after last dose of study drug (Cycle 10 Day 41)
Results posted on
2019-03-14
Participant Flow
Participants took part in the study at 7 investigative sites in the United States from 31 January 2014 to 09 November 2016.
Participants with diagnosis of advanced malignant solid tumors were enrolled in Schedule A of dose escalation phase to receive TAK-243 (MLN7243). The study was terminated prior to start of Schedule B of dose escalation phase and planned expansion because of realignment of the sponsor's pipeline program.
Participant milestones
| Measure |
Schedule A: TAK-243 1 mg
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
4
|
4
|
5
|
8
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
4
|
5
|
8
|
1
|
Reasons for withdrawal
| Measure |
Schedule A: TAK-243 1 mg
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Progressive Disease
|
3
|
3
|
2
|
4
|
2
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
2
|
0
|
Baseline Characteristics
A Dose Escalation Study of MLN7243 (TAK-243) in Adult Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Schedule A: TAK-243 Total
n=29 Participants
TAK-243 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 18 mg, and 4mg homozygous mutant, infusion, IV over 10-minutes, twice-weekly on Days 1, 4, 8, and 11 in a 21-day treatment cycle for a maximum of 12 cycles, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
|
Height
|
170.88 centimeter (cm)
STANDARD_DEVIATION 12.101 • n=5 Participants
|
|
Weight
|
79.69 kilogram (kg)
STANDARD_DEVIATION 16.829 • n=5 Participants
|
|
Body Surface Area
|
1.936 square meter (m^2)
STANDARD_DEVIATION 0.2364 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 10 Day 41)Population: The safety population included all participants who received at least 1 dose of TAK-243.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
3 participants
|
4 participants
|
4 participants
|
4 participants
|
4 participants
|
8 participants
|
1 participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
1 participants
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
4 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 10 Day 41)Population: The safety population included all participants who received at least 1 dose of TAK-243.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Related TEAEs by System Organ Class (SOC)
Metabolism and nutrition disorders
|
1 participants
|
1 participants
|
1 participants
|
3 participants
|
1 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Laboratory Related TEAEs by System Organ Class (SOC)
Blood and lymphatic system disorders
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
4 participants
|
0 participants
|
|
Number of Participants With Laboratory Related TEAEs by System Organ Class (SOC)
Investigations
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 10 Day 41)Population: The safety population included all participants who received at least 1 dose of TAK-243.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Related TEAEs by Preferred Term (PT)
Pyrexia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Sign Related TEAEs by Preferred Term (PT)
Dyspnoea
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Vital Sign Related TEAEs by Preferred Term (PT)
Dyspnoea exertional
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Sign Related TEAEs by Preferred Term (PT)
Hypertension
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 up to Cycle 1 Day 11Population: The safety population included all participants who received at least 1 dose of TAK-243.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 2 up to 30 days after last dose of study drug (Cycle 10 Day 41)Population: The safety population included all participants who received at least 1 dose of TAK-243.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Echocardiogram Abnormalities
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 10 Day 41)Population: The safety population included all participants who received at least 1 dose of TAK-243.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Tropinin I and T
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and 11: pre-infusion to end of infusion (up to 10 minutes)Population: The plasma pharmacokinetic (PK) analysis population where data at specified time points was available.The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Ceoi: Plasma Concentration at the End of Infusion for TAK-243
Cycle 1 Day 1
|
78.658 nanogram per milliliter (ng/mL)
Standard Deviation 48.2212
|
100.758 nanogram per milliliter (ng/mL)
Standard Deviation 24.0669
|
473.075 nanogram per milliliter (ng/mL)
Standard Deviation 132.7667
|
921.804 nanogram per milliliter (ng/mL)
Standard Deviation 258.6109
|
1276.684 nanogram per milliliter (ng/mL)
Standard Deviation 804.4476
|
1775.470 nanogram per milliliter (ng/mL)
Standard Deviation 463.8601
|
391.000 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
|
Ceoi: Plasma Concentration at the End of Infusion for TAK-243
Cycle 1 Day 11
|
68.073 nanogram per milliliter (ng/mL)
Standard Deviation 35.2718
|
129.681 nanogram per milliliter (ng/mL)
Standard Deviation 52.4680
|
273.807 nanogram per milliliter (ng/mL)
Standard Deviation 179.4241
|
2299.438 nanogram per milliliter (ng/mL)
Standard Deviation 9027.7420
|
1271.199 nanogram per milliliter (ng/mL)
Standard Deviation 628.4555
|
2316.282 nanogram per milliliter (ng/mL)
Standard Deviation 7744.9842
|
265.000 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-243
Cycle 1 Day 1
|
32.853 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 17.3894
|
52.845 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 5.6656
|
312.714 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 193.3829
|
368.071 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 8.2218
|
867.427 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 374.1800
|
922.068 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 192.2359
|
—
|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-243
Cycle 1 Day 11
|
30.181 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 12.8884
|
50.337 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 8.9494
|
178.142 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
—
|
—
|
—
|
228.053 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
AUCτ: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for TAK-243
Cycle 1 Day 1
|
—
|
—
|
535.581 ng*hr/mL
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
377.812 ng*hr/mL
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
1132.160 ng*hr/mL
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
922.059 ng*hr/mL
Standard Deviation 192.1773
|
—
|
|
AUCτ: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for TAK-243
Cycle 1 Day 11
|
—
|
—
|
—
|
506.693 ng*hr/mL
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
663.176 ng*hr/mL
Standard Deviation 261.1957
|
771.491 ng*hr/mL
Standard Deviation 181.7875
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-243
Cycle 1 Day 1
|
—
|
—
|
203.043 ng*hr/mL
Standard Deviation 10.0600
|
375.541 ng*hr/mL
Standard Deviation 11.2872
|
579.122 ng*hr/mL
Standard Deviation 201.1755
|
768.728 ng*hr/mL
Standard Deviation 174.9927
|
—
|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-243
Cycle 1 Day 11
|
—
|
—
|
179.726 ng*hr/mL
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
509.785 ng*hr/mL
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
752.152 ng*hr/mL
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
864.533 ng*hr/mL
Standard Deviation 175.9351
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
CL: Total Clearance After Intravenous Administration for TAK-243
Cycle 1 Day 1
|
—
|
—
|
19.724 liter per hour (L/hr)
Standard Deviation 0.9773
|
21.312 liter per hour (L/hr)
Standard Deviation 0.6406
|
22.749 liter per hour (L/hr)
Standard Deviation 8.8967
|
24.379 liter per hour (L/hr)
Standard Deviation 5.6587
|
—
|
|
CL: Total Clearance After Intravenous Administration for TAK-243
Cycle 1 Day 11
|
—
|
—
|
22.162 liter per hour (L/hr)
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
15.789 liter per hour (L/hr)
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
16.194 liter per hour (L/hr)
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
21.558 liter per hour (L/hr)
Standard Deviation 4.8376
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Vss: Volume of Distribution at Steady State for TAK-243
Cycle 1 Day 1
|
—
|
—
|
29.806 liter
Standard Deviation 0.9494
|
33.957 liter
Standard Deviation 5.8273
|
37.596 liter
Standard Deviation 20.7520
|
63.744 liter
Standard Deviation 39.5945
|
—
|
|
Vss: Volume of Distribution at Steady State for TAK-243
Cycle 1 Day 11
|
—
|
—
|
34.120 liter
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
39.618 liter
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
56.573 liter
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
51.806 liter
Standard Deviation 18.8787
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; Cycle 1 Day 11Population: No data were collected as no participant was analyzed since study was terminated before the planned expansion phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 1; Cycle 1 Day 11Population: No data were collected as no participant was analyzed since study was terminated before the planned expansion phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Terminal Phase Elimination Half-life (T1/2) for TAK-243
Cycle 1 Day 1
|
—
|
—
|
7.001 hour
Standard Deviation 1.4372
|
9.377 hour
Standard Deviation 4.6442
|
5.765 hour
Standard Deviation 0.8607
|
8.296 hour
Standard Deviation 4.3573
|
—
|
|
Terminal Phase Elimination Half-life (T1/2) for TAK-243
Cycle 1 Day 11
|
—
|
—
|
5.572 hour
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
15.212 hour
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
27.446 hour
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
9.873 hour
Standard Deviation 6.3030
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 1 Day 12Population: Pharmacodynamic population:baseline,post-baseline assessments were available,including all participants who received all doses(Cycle 1),have pre-post dose paired tumor tissue biopsies taken at protocol-specified timepoints,have sufficient tumor content at both timepoints to estimate changes in Pharmacodynamic biomarker percent area positive values.
The pharmacodynamics IHC biomarkers included polyubiquitin marker and ubquityl (Ub)-histone H2B marker. H-score was a composite score that comprised of intensity and percentage of staining and was used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=1 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=1 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=1 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Immunohistochemistry (IHC) Biomarkers in Tumor Biopsies at Cycle 1 Day 12 (C1D12) as Assessed by Histological Score (H-score)
Baseline: Polyubiquitin H-score
|
286.00 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
297.80 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
282.00 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Immunohistochemistry (IHC) Biomarkers in Tumor Biopsies at Cycle 1 Day 12 (C1D12) as Assessed by Histological Score (H-score)
Change at C1D12: Polyubiquitin H-score
|
-3.60 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
-2.00 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
4.20 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Immunohistochemistry (IHC) Biomarkers in Tumor Biopsies at Cycle 1 Day 12 (C1D12) as Assessed by Histological Score (H-score)
Baseline: Ub-histone H2B H-score
|
269.750 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
291.000 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
290.750 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Immunohistochemistry (IHC) Biomarkers in Tumor Biopsies at Cycle 1 Day 12 (C1D12) as Assessed by Histological Score (H-score)
Change at C1D12: Ub-histone H2B H-score
|
13.250 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
3.250 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
2.000 score on a scale
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 1 Day 12Population: Pharmacodynamic population:baseline,post-baseline assessments were available,including all participants who received all doses(Cycle 1),have pre-post dose paired tumor tissue biopsies taken at protocol-specified timepoints,have sufficient tumor content at both timepoints to estimate changes in Pharmacodynamic biomarker percent area positive values.
The pharmacodynamics IHC biomarkers included polyubiquitin marker and Ub-histone H2B marker. Positive index was calculated by taking the number of positive cells over the total number of cells.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=1 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=1 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=1 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in IHC Biomarkers in Tumor Biopsies at C1D12 as Assessed by Positive Index
Baseline: Polyubiquitin Positive Index
|
0.99 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
1.00 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
0.99 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in IHC Biomarkers in Tumor Biopsies at C1D12 as Assessed by Positive Index
Change at C1D12: Polyubiquitin Positive Index
|
-0.01 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
0.00 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
0.00 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in IHC Biomarkers in Tumor Biopsies at C1D12 as Assessed by Positive Index
Baseline: Ub-histone H2B Positive Index
|
0.953 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
0.995 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
0.990 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in IHC Biomarkers in Tumor Biopsies at C1D12 as Assessed by Positive Index
Change at C1D12: Ub-histone H2B Positive Index
|
0.018 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
0.003 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
-0.003 percentage of cell
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 7 months)Population: The response-evaluable population included all participants who received at least 1 dose of TAK-243, have measurable disease at baseline, and have at least 1 post baseline disease assessment.
Best overall response for participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target and non target) must have reduction in short axis to less than (\<) 10 millimeter (mm). Partial Response (PR): at least 30 percent (%) decrease in sum of diameter of target lesions, taking as reference baseline sum of diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameter; PD: at least 20% increase in sum of diameter of target lesions, taking as reference, smallest sum on study (this includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least mm. The appearance of 1 or more new lesions is also considered progression.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=3 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 Participants
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=2 Participants
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=3 Participants
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=2 Participants
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=5 Participants
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 Participants
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response
CR
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Best Overall Response
PR
|
33 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Best Overall Response
SD
|
67 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
50 percentage of participants
|
60 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Best Overall Response
PD
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
50 percentage of participants
|
40 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 7 months)Population: The response-evaluable population where baseline and post-baseline assessments were available. The Response-evaluable population included all participants who received at least 1 dose of TAK-243, have measurable disease at baseline, and have at least 1 post baseline disease assessment.
Duration of any response (CR or PR) was defined as the time (in both days and months) from the date of first documented response per the investigator response assessment to the date of first progressive disease after the first documented response or, if the participant discontinues treatment, the date of last disease assessment as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target and non target) must have reduction in short axis to \<10 mm. PR: at least 30% decrease in sum of diameter of target lesions, taking as reference baseline sum of diameter.
Outcome measures
| Measure |
Schedule A: TAK-243 1 mg
n=1 Participants
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Duration of Response
|
6.24 months
Interval 6.24 to 6.24
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Schedule A: TAK-243 1 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Schedule A: TAK-243 2 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Schedule A: TAK-243 4 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Schedule A: TAK-243 8 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Schedule A: TAK-243 12 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Schedule A: TAK-243 18 mg
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Schedule A: TAK-243 Homozygous Mutant 4 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Schedule A: TAK-243 1 mg
n=3 participants at risk
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 participants at risk
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 participants at risk
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 participants at risk
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 participants at risk
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 participants at risk
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 participants at risk
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viraemia and fungaemia not elsewhere classified (NEC)
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Duodenal and small intestinal stenosis and obstruction
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence, bloating and distension
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Breathing abnormalities
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Schedule A: TAK-243 1 mg
n=3 participants at risk
TAK-243 (MLN7243) 1 milligram (mg), infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or disease progression (PD) or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 2 mg
n=4 participants at risk
TAK-243 (MLN7243) 2 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD, or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 4 mg
n=4 participants at risk
TAK-243 (MLN7243) 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 8 mg
n=4 participants at risk
TAK-243 (MLN7243) 8 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 12 mg
n=5 participants at risk
TAK-243 (MLN7243) 12 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 18 mg
n=8 participants at risk
TAK-243 (MLN7243) 18 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
Schedule A: TAK-243 Homozygous Mutant 4 mg
n=1 participants at risk
TAK-243 (MLN7243) homozygous mutant 4 mg, infusion, intravenously over 10-minutes, on Days 1, 4, 8, and 11 followed by 10 days of rest in a 21-day treatment cycle for a maximum of 12 months, or until symptomatic deterioration or PD or discontinuation of study for another reason, or until study is stopped.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
4/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
75.0%
3/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
4/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
40.0%
2/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site erythema
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device site bruise
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device site phlebitis
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abscess oral
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Furuncle
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Liver function test increased
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Troponin T increased
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
2/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
33.3%
1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Cycle 10 Day 41) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER