Trial Outcomes & Findings for Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma (NCT NCT01454076)
NCT ID: NCT01454076
Last Updated: 2017-11-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
112 participants
Primary outcome timeframe
Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hours[hrs])post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose
Results posted on
2017-11-01
Participant Flow
Participants took part in the study at 4 investigative sites in the United States from 10 November 2011 to 16 June 2016. An additional 1 center was activated but did not screen or enroll any participants.
Participants with advanced nonhematologic malignancies or lymphoma were enrolled in this 5 arm study to receive one of the following treatments in Cycle 1: ixazomib + ketoconazole; ixazomib Capsule A or B formulation; ixazomib in fasted or fed state; ixazomib + rifampin; ixazomib + clarithromycin; Cycle 2 up to Cycle 12: ixazomib alone in all arms.
Participant milestones
| Measure |
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 milligram (mg), capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 2: Ixazomib 4 mg Capsule A or B
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 3: Ixazomib 4 mg Fasted or Fed
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
20
|
24
|
18
|
21
|
|
Overall Study
COMPLETED
|
16
|
14
|
15
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
9
|
2
|
6
|
Reasons for withdrawal
| Measure |
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Ixazomib 2.5 milligram (mg), capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 2: Ixazomib 4 mg Capsule A or B
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 3: Ixazomib 4 mg Fasted or Fed
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Other
|
2
|
0
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
2
|
1
|
2
|
|
Overall Study
Adverse Event
|
8
|
2
|
7
|
0
|
2
|
Baseline Characteristics
Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma
Baseline characteristics by cohort
| Measure |
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
n=29 Participants
Ixazomib 2.5 milligram (mg), capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 2: Ixazomib 4 mg Capsule A or B
n=20 Participants
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 3: Ixazomib 4 mg Fasted or Fed
n=24 Participants
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
n=18 Participants
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
n=21 Participants
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 8.71 • n=93 Participants
|
60.5 years
STANDARD_DEVIATION 13.33 • n=4 Participants
|
62.3 years
STANDARD_DEVIATION 11.86 • n=27 Participants
|
61.6 years
STANDARD_DEVIATION 11.33 • n=483 Participants
|
60.0 years
STANDARD_DEVIATION 11.04 • n=36 Participants
|
61.3 years
STANDARD_DEVIATION 11.01 • n=10 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
53 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
59 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
96 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
91 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=93 Participants
|
20 participants
n=4 Participants
|
24 participants
n=27 Participants
|
18 participants
n=483 Participants
|
21 participants
n=36 Participants
|
112 participants
n=10 Participants
|
|
Height
|
166.6 centimeter (cm)
STANDARD_DEVIATION 9.26 • n=93 Participants
|
166.4 centimeter (cm)
STANDARD_DEVIATION 9.64 • n=4 Participants
|
170.2 centimeter (cm)
STANDARD_DEVIATION 9.76 • n=27 Participants
|
169.2 centimeter (cm)
STANDARD_DEVIATION 10.03 • n=483 Participants
|
172.6 centimeter (cm)
STANDARD_DEVIATION 11.11 • n=36 Participants
|
168.9 centimeter (cm)
STANDARD_DEVIATION 10.00 • n=10 Participants
|
|
Weight
|
77.44 kilogram (kg)
STANDARD_DEVIATION 19.956 • n=93 Participants
|
69.78 kilogram (kg)
STANDARD_DEVIATION 13.057 • n=4 Participants
|
74.09 kilogram (kg)
STANDARD_DEVIATION 16.358 • n=27 Participants
|
80.22 kilogram (kg)
STANDARD_DEVIATION 17.183 • n=483 Participants
|
81.93 kilogram (kg)
STANDARD_DEVIATION 20.973 • n=36 Participants
|
76.64 kilogram (kg)
STANDARD_DEVIATION 18.083 • n=10 Participants
|
PRIMARY outcome
Timeframe: Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hours[hrs])post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dosePopulation: The pharmacokinetic (PK)-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.
Outcome measures
| Measure |
Arm 1: Ixazomib 2.5 mg
n=16 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
|
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
n=16 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule A
n=14 Participants
Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule B
n=14 Participants
Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fasted
n=15 Participants
Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fed
n=15 Participants
Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
n=16 Participants
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
n=15 Participants
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
|
|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Ixazomib
|
38.975 nanogram per milliliter (ng/mL)
Standard Deviation 21.3727
|
39.250 nanogram per milliliter (ng/mL)
Standard Deviation 27.3318
|
61.866 nanogram per milliliter (ng/mL)
Standard Deviation 48.3909
|
71.949 nanogram per milliliter (ng/mL)
Standard Deviation 46.2132
|
77.001 nanogram per milliliter (ng/mL)
Standard Deviation 53.5905
|
22.752 nanogram per milliliter (ng/mL)
Standard Deviation 15.0506
|
25.706 nanogram per milliliter (ng/mL)
Standard Deviation 15.1435
|
37.245 nanogram per milliliter (ng/mL)
Standard Deviation 21.4416
|
PRIMARY outcome
Timeframe: Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dosePopulation: The PK-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.
Outcome measures
| Measure |
Arm 1: Ixazomib 2.5 mg
n=16 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
|
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
n=16 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule A
n=14 Participants
Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule B
n=14 Participants
Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fasted
n=15 Participants
Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fed
n=15 Participants
Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
n=16 Participants
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
n=15 Participants
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
|
|---|---|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib
|
551.985 nanogram*hour per milliliter (ng*hr/mL)]
Standard Deviation 191.4490
|
1148.778 nanogram*hour per milliliter (ng*hr/mL)]
Standard Deviation 581.4376
|
1284.079 nanogram*hour per milliliter (ng*hr/mL)]
Standard Deviation 941.4838
|
1334.659 nanogram*hour per milliliter (ng*hr/mL)]
Standard Deviation 1244.0951
|
1465.979 nanogram*hour per milliliter (ng*hr/mL)]
Standard Deviation 812.0514
|
998.698 nanogram*hour per milliliter (ng*hr/mL)]
Standard Deviation 1019.1868
|
231.527 nanogram*hour per milliliter (ng*hr/mL)]
Standard Deviation 134.9720
|
613.112 nanogram*hour per milliliter (ng*hr/mL)]
Standard Deviation 375.0216
|
PRIMARY outcome
Timeframe: Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dosePopulation: The PK-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.
Outcome measures
| Measure |
Arm 1: Ixazomib 2.5 mg
n=16 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
|
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
n=16 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule A
n=14 Participants
Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule B
n=14 Participants
Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fasted
n=15 Participants
Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fed
n=15 Participants
Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
n=16 Participants
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
n=15 Participants
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
|
|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
|
1.090 hours
Interval 0.47 to 2.07
|
1.500 hours
Interval 0.5 to 4.17
|
1.290 hours
Interval 0.52 to 3.0
|
1.250 hours
Interval 0.5 to 7.5
|
1.020 hours
Interval 0.48 to 4.0
|
4.000 hours
Interval 1.93 to 8.03
|
1.450 hours
Interval 0.5 to 4.12
|
1 hours
Interval 0.42 to 7.18
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45)Population: The safety population included all participants who received at least one dose of any study drug.
Outcome measures
| Measure |
Arm 1: Ixazomib 2.5 mg
n=29 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
|
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
n=20 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule A
n=24 Participants
Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule B
n=18 Participants
Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fasted
n=21 Participants
Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fed
Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
29 participants
|
20 participants
|
24 participants
|
18 participants
|
21 participants
|
—
|
—
|
—
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
12 participants
|
5 participants
|
12 participants
|
3 participants
|
10 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45Population: The safety population included all participants who received at least one dose of any study drug.
Outcome measures
| Measure |
Arm 1: Ixazomib 2.5 mg
n=29 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
|
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
n=20 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule A
n=24 Participants
Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule B
n=18 Participants
Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fasted
n=21 Participants
Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fed
Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities
Blood and lymphatic system disorders
|
11 participants
|
7 participants
|
9 participants
|
2 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities
Investigations
|
10 participants
|
5 participants
|
11 participants
|
4 participants
|
5 participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities
Metabolism and nutrition disorders
|
22 participants
|
12 participants
|
13 participants
|
6 participants
|
6 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45Population: The safety population included all participants who received at least one dose of any study drug.
Outcome measures
| Measure |
Arm 1: Ixazomib 2.5 mg
n=29 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
|
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
n=20 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule A
n=24 Participants
Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule B
n=18 Participants
Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fasted
n=21 Participants
Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fed
Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Abnormalities
|
0 participants
0.324
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of treatment (approximately 1.9 years)Population: The response-evaluable population included participants who had measurable disease at baseline, received at least 1 dose of any study drug, and had at least 1 postbaseline response assessment.
Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (\<) 10 millimeter \[mm\]). No new lesions. Partial response (PR) was defined as greater than or equal to (\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, Progressive Disease (PD). An increase of \>=20% from the nadir (or baseline, if it represents the point at which the sum of target disease was lowest) represents PD.
Outcome measures
| Measure |
Arm 1: Ixazomib 2.5 mg
n=16 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 of Cycle 1 (28-day treatment cycle).
|
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
n=14 Participants
Ixazomib 2.5 mg, capsule B, orally, once on Day 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule A
n=17 Participants
Ixazomib 4 mg, capsule A, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 2: Ixazomib 4 mg Capsule B
n=17 Participants
Ixazomib 4 mg, capsule B, orally, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fasted
n=18 Participants
Ixazomib 4 mg, capsule B, orally, under fasted conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 3: Ixazomib 4 mg Fed
Ixazomib 4 mg, capsule B, orally, under fed conditions, once on Day 1 or 15 of Cycle 1 (28-day treatment cycle).
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle).
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response
SD
|
63 percentage of participants
Interval 35.4 to 84.8
|
50 percentage of participants
Interval 23.0 to 77.0
|
35 percentage of participants
Interval 14.2 to 61.7
|
53 percentage of participants
Interval 27.8 to 77.0
|
53 percentage of participants
Interval 27.8 to 77.0
|
—
|
—
|
—
|
|
Percentage of Participants With Best Overall Response
CR
|
0 percentage of participants
Interval 0.0 to 20.6
|
0 percentage of participants
Interval 0.0 to 23.2
|
0 percentage of participants
Interval 0.0 to 19.5
|
0 percentage of participants
Interval 0.0 to 19.5
|
0 percentage of participants
Interval 0.0 to 4.5
|
—
|
—
|
—
|
|
Percentage of Participants With Best Overall Response
PR
|
0 percentage of participants
Interval 0.0 to 20.6
|
0 percentage of participants
Interval 0.0 to 23.2
|
6 percentage of participants
Interval 0.1 to 28.7
|
0 percentage of participants
Interval 0.0 to 19.5
|
1 percentage of participants
Interval 0.0 to 6.7
|
—
|
—
|
—
|
|
Percentage of Participants With Best Overall Response
PD
|
38 percentage of participants
Interval 15.2 to 64.6
|
50 percentage of participants
Interval 23.0 to 77.0
|
59 percentage of participants
Interval 32.9 to 81.6
|
47 percentage of participants
Interval 23.0 to 72.2
|
47 percentage of participants
Interval 23.0 to 72.2
|
—
|
—
|
—
|
Adverse Events
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
Serious events: 12 serious events
Other events: 28 other events
Deaths: 0 deaths
Arm 2: Ixazomib 4 mg Capsule A or B
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Arm 3: Ixazomib 4 mg Fasted or Fed
Serious events: 12 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
Serious events: 10 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
n=29 participants at risk
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 2: Ixazomib 4 mg Capsule A or B
n=20 participants at risk
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 3: Ixazomib 4 mg Fasted or Fed
n=24 participants at risk
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
n=18 participants at risk
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
n=21 participants at risk
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Pyrexia
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Face oedema
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Pain
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Sepsis
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Sepsis syndrome
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Anorectal infection
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
3/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Interstitial granulomatous dermatitis
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
Other adverse events
| Measure |
Arm 1: Ixazomib 2.5 mg + Ketoconazole 400 mg
n=29 participants at risk
Ixazomib 2.5 mg, capsule B, orally, once on Day 1 and 15 along with ketoconazole 400 mg, tablets, orally, once daily from Day 12 to 25 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 2: Ixazomib 4 mg Capsule A or B
n=20 participants at risk
Ixazomib 4 mg, capsule A, orally, once on Day 1 followed by ixazomib 4 mg, capsule B once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, once on Day 1 followed by ixazomib 4 mg, capsule A once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 3: Ixazomib 4 mg Fasted or Fed
n=24 participants at risk
Ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fed state, once on Day 15 of Cycle 1 (28-day treatment cycle) or ixazomib 4 mg, capsule B, orally, under fed state, once on Day 1 followed by ixazomib 4 mg, capsule B, orally, under fasted state, once on Day 15 of Cycle 1 (28-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 4: Ixazomib 4 mg + Rifampin 600 mg
n=18 participants at risk
Ixazomib, 4 mg, capsule B, orally, once on Day 8 along with rifampin 600 mg, capsule, orally, once daily from Day 1 to 14 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
Arm 5: Ixazomib 2.5 mg + Clarithromycin 500 mg
n=21 participants at risk
Ixazomib, 2.5 mg, capsule B, orally, once on Day 6 along with clarithromycin, 500 mg, tablet, orally, twice daily from Day 1 to 16 of Cycle 1 (21-day treatment cycle). After Cycle 1, participants received ixazomib 4 mg, capsule B, orally, once daily on Days 1, 8 and 15 of each cycle (28-day treatment cycle) up to a maximum of 12 cycles, until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.7%
6/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Immune system disorders
Seasonal allergy
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Eye disorders
Eye swelling
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Eye disorders
Eye discharge
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Vascular disorders
Hypotension
|
10.3%
3/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Vascular disorders
Hot flush
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Oral candidiasis
|
10.3%
3/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
3/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Herpes zoster
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
17.2%
5/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
13.8%
4/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Psychiatric disorders
Confusional state
|
10.3%
3/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
13.8%
4/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Headache
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
14.3%
3/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
24.1%
7/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
20.0%
4/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
25.0%
6/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
12.5%
3/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
Weight decreased
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
25.0%
6/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
14.3%
3/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
16.7%
4/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
10.3%
3/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
International normalised ratio increased
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
Platelet count decreased
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
Blood creatine increased
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
15.0%
3/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
16.7%
4/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
4/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
15.0%
3/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
16.7%
4/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
23.8%
5/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
20.8%
5/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
19.0%
4/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
15.0%
3/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
15.0%
3/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
16.7%
3/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.3%
3/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin wrinkling
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
13.8%
4/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
16.7%
4/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
17.2%
5/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.3%
3/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
12.5%
3/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Ascites
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Tongue atrophy
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
44.8%
13/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
35.0%
7/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
25.0%
6/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
22.2%
4/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
23.8%
5/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
20.8%
5/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.9%
2/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
16.7%
4/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.8%
4/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Fatigue
|
69.0%
20/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
35.0%
7/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
37.5%
9/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
44.4%
8/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
38.1%
8/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Asthenia
|
37.9%
11/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
20.0%
4/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
20.8%
5/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Chills
|
17.2%
5/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Malaise
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
10.0%
2/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.8%
1/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
9.5%
2/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
General disorders
Peripheral swelling
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
4.2%
1/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
11.1%
2/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Product Issues
Device occlusion
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
8.3%
2/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Infections and infestations
Conjunctivitis
|
3.4%
1/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.0%
1/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/29 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/20 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/24 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
5.6%
1/18 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment.
|
0.00%
0/21 • Treatment-emergent adverse events are adverse events that started after first dose of study drug and no more than 30 days for a serious adverse event after last dose of study drug (Cycle 25 Day 45)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of 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